CN111447897A - Ostomy appliance with angular leak detection - Google Patents

Abstract

A base plate and/or sensor assembly portion for an ostomy appliance and related methods are disclosed, the base plate and/or sensor assembly portion comprising: a first adhesive layer having a proximal side configured for attaching the base plate and/or the sensor assembly portion to a skin surface of a user, the first adhesive layer having a stoma opening with a center point; and a plurality of electrodes including a first leakage electrode, a second leakage electrode, and a third leakage electrode, wherein the plurality of electrodes are configured to detect the presence of fluid on a proximal side of the first adhesive layer in a primary sensing zone and a secondary sensing zone, the primary sensing zone being arranged in a primary angular space from a center point of the first adhesive layer and the secondary sensing zone being arranged in a secondary angular space from a center point of the first adhesive layer.

Description

Ostomy appliance with angular leak detection

The present disclosure relates to a base plate and/or a sensor assembly part for an ostomy appliance. An ostomy system, and an appliance for an ostomy system are also disclosed. The ostomy appliance system comprises an ostomy appliance and a monitoring device. In particular, the present disclosure relates to a base plate and/or sensor assembly and an ostomy appliance capable of enabling or facilitating leakage classification and/or detection, and/or monitoring operation of the ostomy appliance.

Drawings

The accompanying drawings are included to provide a further understanding of the embodiments, and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain the principles of the embodiments. Many of the intended advantages of other embodiments and embodiments will be readily appreciated, as they will become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.

Figure 1 shows an exemplary ostomy system in which,

figure 2 shows an exemplary monitoring device of an ostomy system,

figure 3 is an exploded view of a base plate of an ostomy appliance,

figure 4 is an exploded view of an exemplary electrode assembly,

figure 5 is a proximal side view of a portion of the base plate and/or sensor assembly portion,

figure 6 is a distal view of an exemplary electrode configuration,

figure 7 is a distal view of an exemplary masking element,

figure 8 is a distal view of an exemplary first adhesive layer,

figure 9 is a proximal side view of the first adhesive layer of figure 8,

figure 10 is a distal view of a portion of a base plate and/or sensor assembly portion including a monitor interface,

figure 11 is a distal view of the electrode configuration of figure 6,

figure 12 is a distal view of an exemplary electrode configuration,

figure 13 is a distal view of an exemplary masking element,

figure 14 is a distal view of an exemplary first adhesive layer,

FIG. 15 is a distal view of an exemplary electrode configuration, an

FIG. 16 is a flow chart of an exemplary method.

Detailed Description

In the following, various exemplary embodiments and details are described with reference to the accompanying drawings, when relevant. It should be noted that the figures may or may not be drawn to scale and that elements having similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to assist the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. Moreover, the embodiments shown do not necessarily have all aspects or advantages shown. Aspects or advantages described in connection with a particular embodiment are not necessarily limited to that embodiment, and may be practiced in any other embodiment, even if not so shown or not so explicitly described.

Throughout this disclosure, the words "stoma" and "ostomy" are used to denote an opening formed by surgery that bypasses the human intestinal or urinary tract system. These terms are used interchangeably and have no distinguishing meaning. The same applies to any word or phrase derived from these words, such as "ostomy", and the like. Furthermore, both solid and liquid waste coming out of the stoma may be interchangeably referred to as stoma "discharge", "waste" and "fluid". A subject undergoing an ostomy procedure may be referred to as an "ostomate" or "ostomate", and further, also as a "patient" or "user". However, in some cases, a "user" may also refer to or refer to a healthcare professional (HCP), such as a surgeon or an ostomy care nurse or others. In these cases, it will be stated explicitly or implied from the context that the "user" is not the "patient" himself or herself.

In the following, whenever reference is made to a proximal side or surface of a layer, element, device or a part of a device, reference is made to the skin facing side or surface when the user wears the ostomy appliance. Likewise, whenever reference is made to a distal side or surface of a layer, element, device or a part of a device, reference is made to the side or surface facing away from the skin when the ostomy appliance is worn by the user. In other words, the proximal side or surface is the side or surface closest to the user when the appliance is fitted to the user, and the distal side is the opposite side or surface is the side or surface furthest from the user in use.

The axial direction is defined as the direction of the stoma when the appliance is worn by a user. Thus, the axial direction is substantially perpendicular to the skin or abdominal surface of the user.

The radial direction is defined as being perpendicular to the axial direction. In some statements, the words "inner" and "outer" may be used. These definitions should generally be understood with reference to a radial direction, such that reference to an "outer" element means that the element is further away from the central part of the ostomy appliance than an element referred to as "inner". Further, "innermost" should be interpreted as that portion of the component that forms the center of the component and/or is adjacent to the center of the component. Similarly, "outermost" should be interpreted as that part which forms and/or is adjacent to the outer edge or outer contour of the component.

The use of the word "substantially" in this disclosure as a modifier of certain features or effects is intended to simply indicate that any deviation is within the tolerance normally expected by a person skilled in the relevant art.

The use of the word "generally" in this disclosure as a modifier of certain features or effects is intended to simply mean: for structural features, most or a major portion of such features exhibit the properties in question; for a functional feature or effect, most results relating to the property provide the effect, but exceptional results do not.

The present disclosure relates to an ostomy system and devices thereof, such as an ostomy appliance, a base plate for an ostomy appliance, a monitoring device, and optionally one or more accessory devices. Additionally, methods related to ostomy systems and devices thereof are disclosed. The accessory device (also referred to as an external device) may be a mobile phone or other handheld device. The accessory device may be a personal electronic device, for example a wearable device, such as a watch or other wrist-worn electronic device. The accessory device may be a docking station. The docking station may be configured to electrically and/or mechanically couple the monitoring device to the docking station. The docking station may be configured to charge the monitoring device and/or configured to communicate data between the monitoring device and the docking station. The ostomy system may comprise a server device. The server device may be operated and/or controlled by an ostomy appliance manufacturer and/or a service center.

The present disclosure provides an ostomy system and devices thereof, such as an ostomy appliance, a base plate for an ostomy appliance, a monitoring device, and optionally one or more accessory devices, which individually or together facilitate a reliable determination of the nature, severity and rapidity of moisture spread in an adhesive material provided for attaching the base plate to a skin surface of a user. Depending on the nature of the mode of moisture spreading in the adhesive, the ostomy system and its device can provide the user with information about the type of failure and can in turn provide the user with an indication of the severity and thus the remaining time frame for replacing the ostomy appliance without severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy bag (also called ostomy bag). The ostomy appliance may be a colostomy appliance, an ileostomy appliance or a urostomy appliance. The ostomy appliance may be a two-piece ostomy appliance, i.e. the base plate and the ostomy bag may be releasably coupled, e.g. by a mechanical and/or adhesive coupling, e.g. to allow that one base plate may be used (exchanged) with a plurality of ostomy bags. In addition, a two-piece ostomy appliance may facilitate correct application of the base plate to the skin, for example to obtain an improved view of the stoma area by the user. The ostomy appliance may be a one-piece ostomy appliance, i.e. the base plate and the ostomy bag may be securely attached to each other. The base plate is configured for coupling to a stoma of a user and/or to skin surrounding the stoma, such as a stoma-surrounding skin area.

The ostomy appliance comprises, for example, a base plate integrated with the sensor assembly part, such as a one-piece base plate of metal, or a base plate and a separate sensor assembly part, such as a sensor assembly part subsequently applied to the base plate. For example, to allow any backplane, such as a conventional backplane, to implement features as described herein. The sensor assembly portion may be applied to the base plate, for example by a user, to provide the features as described herein with respect to the base plate. The sensor assembly portion may be adapted to adhere to the ostomy plate.

The disclosed method for attaching a base plate to a stoma and/or to the skin surrounding the stoma of a user, such as a peristomal skin area, may comprise: the sensor assembly part is attached to the base plate and the base plate, e.g. together with the attached sensor assembly part, is attached to the stoma and/or to the skin surrounding the stoma of the user, such as a peristomal skin area. Alternatively, the method for attaching a base plate to a stoma and/or to the skin around the stoma of a user may comprise: the sensor assembly part is attached to the stoma and/or the skin around the stoma of the user and the base plate is attached to the stoma and/or the skin around the stoma of the user over the attached sensor assembly part.

A base plate and/or a sensor assembly part for an ostomy appliance is disclosed, the base plate and/or the sensor assembly part comprising: a first adhesive layer having a proximal side configured for attaching the base plate and/or the sensor assembly portion to a skin surface of a user, the first adhesive layer having a stoma opening with a center point, such as a first adhesive stoma opening; and a plurality of electrodes including a first leakage electrode, a second leakage electrode, and a third leakage electrode, wherein the plurality of electrodes are configured to detect the presence of fluid in a primary sensing zone and a secondary sensing zone on a proximal side of the first adhesive layer. The primary sensing region may be disposed in a primary angular space from a center point of the first adhesive layer, and/or the secondary sensing region may be disposed in a secondary angular space from a center point of the first adhesive layer. Alternatively or additionally, the primary sensing zone may be arranged in a primary radial space from a central point of the first adhesive layer, and the secondary sensing zone may be arranged in a secondary radial space from a central point of the first adhesive layer.

Furthermore, a monitoring device for an ostomy system is disclosed. The ostomy system comprises an ostomy appliance having a base plate and/or a sensor assembly part such as also described herein, such as a base plate and/or a sensor assembly part having a first adhesive layer having a proximal side configured for attaching the base plate and/or the sensor assembly part to a skin surface of a user, said first adhesive layer having a stoma opening with a centre point. The monitoring device includes: a processor; a memory; a first interface connected to the processor and the memory; and a second interface connected to the processor. The first interface is configured to obtain ostomy data from a base plate and/or a sensor assembly portion coupled to the first interface. The ostomy data comprises primary leakage ostomy data from primary electrode sets of the base plate and/or sensor assembly portion and secondary leakage ostomy data from secondary electrode sets of the base plate and/or sensor assembly portion. The processor is configured to: obtaining primary leakage parameter data based on the primary leakage ostomy data; obtaining secondary leak parameter data based on the secondary leak ostomy data; detecting the presence of fluid on a proximal side of the first adhesive layer based on the primary leak parameter data in a primary sensing zone, which may be arranged in a primary angular space from a center point of the first adhesive layer, and/or in a primary radial space from a center point of the first adhesive layer; detecting the presence of fluid on a proximal side of the first adhesive layer based on the secondary leakage parameter data in a secondary sensing zone, which may be arranged in a secondary angular space from a center point of the first adhesive layer, and/or in a secondary radial space from a center point of the first adhesive layer; in accordance with detecting the presence of fluid in the primary sensing zone, transmitting a primary leak monitor signal via the second interface, the primary leak monitor signal containing monitor data indicative of the presence of fluid in the primary sensing zone; and in accordance with detecting the presence of fluid in the secondary sensing zone, transmitting a secondary leak monitor signal via the second interface, the secondary leak monitor signal including monitor data indicative of the presence of fluid in the secondary sensing zone.

Furthermore, a method for monitoring a base plate and/or a sensor assembly part of an ostomy appliance is disclosed, the base plate and/or sensor assembly part comprising a first adhesive layer having a proximal side configured for attaching the base plate and/or sensor assembly part onto a skin surface of a user and a stoma opening with a centre point, such as a first adhesive stoma opening, and a plurality of electrodes comprising a first leakage electrode, a second leakage electrode, and a third leakage electrode. The method comprises the following steps: obtaining a primary sensor signal (primary leak ostomy data) from the first and second leak electrodes; detecting the presence of fluid in a primary sensing zone on the proximal side based on the primary sensor signal (primary leak ostomy data); obtaining a secondary sensor signal from the second and third leakage electrodes or from the first and third leakage electrodes (secondary leakage ostomy data); detecting the presence of fluid in a secondary sensing zone on the proximal side based on the secondary sensor signal (secondary leak ostomy data); and in response to detecting the presence of fluid in the primary and/or secondary sensing zones, providing a leak indicator to indicate that the sensing zone has been detected to be in the presence of liquid. The method may be performed with the backplane and/or the sensor assembly portion described herein.

The method may include: obtaining a tertiary sensor signal (tertiary leak ostomy data) from two leak electrodes; detecting the presence of fluid in a tertiary sensing zone on the proximal side based on the tertiary sensor signal (tertiary leak ostomy data); and in accordance with detecting the presence of fluid in the tertiary sensing zone, providing a leak indicator to indicate the sensing zone that the presence of liquid has been detected.

The method may include: obtaining quaternary sensor signals from two leaky electrodes (quaternary leaky ostomy data); detecting the presence of fluid in a quaternary sensing zone on the proximal side based on the quaternary sensor signal (quaternary leak ostomy data); and in response to detecting the presence of fluid in the quaternary sensing zone, providing a leak indicator to indicate the sensing zone that the presence of liquid has been detected.

The base plate and/or the sensor assembly portion includes a first adhesive layer. During use, the first adhesive layer adheres to the skin of the user (stoma perimeter area) and/or to additional sealing elements, such as sealing pastes, sealing tapes and/or sealing rings. Thus, the first adhesive layer may be configured for attaching the base plate and/or the sensor assembly portion to a skin surface of a user. The first adhesive layer has a stoma opening with a centre point, such as a first adhesive stoma opening, or is at least prepared for forming a stoma opening with a centre point. The chassis and/or sensor assembly portion according to the present disclosure is capable of detecting the presence and angular position of fluid or effluent on the proximal side of the first adhesive layer (between the skin surface of the user and the proximal surface of the first adhesive layer).

The first adhesive layer may be made of a first composition. The first composition may include one or more of polyisobutylene and/or styrene-isoprene-styrene. The first composition may comprise one or more hydrocolloids. The first composition may comprise one or more water soluble or water swellable hydrocolloids.

The first composition may be a pressure sensitive adhesive composition suitable for medical purposes comprising a rubbery elastomeric substrate and one or more water soluble or water swellable hydrocolloids. The first composition may include one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of polybutene and the absorption properties of hydrocolloids makes the first composition suitable for use in ostomy appliances. The styrene copolymer may be, for example, a styrene-butadiene-styrene block copolymer, or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are employed. The amount of styrene block copolymer may be from 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is Polyisobutylene (PIB). Hydrocolloids suitable for incorporation in the first composition are selected from natural hydrocolloids, semi-synthetic hydrocolloids, and synthetic hydrocolloids. The first composition may comprise 20% to 60% hydrocolloid. A preferred hydrocolloid is carboxymethyl cellulose (CMC). The first composition may optionally comprise other components such as fillers, tackifiers, plasticizers, and other additives.

An advantage of the present disclosure is that an optimal or improved use of an ostomy appliance is provided. In particular, the present disclosure facilitates that the chassis is not replaced too late (resulting in adhesive failure, leakage, and/or skin damage), or at least that the user is informed that a leakage is about to occur, is occurring, or has occurred. Thus, the user or healthcare professional is able to monitor and plan the use of the ostomy appliance.

Additionally, determining the type of moisture pattern or angular leakage pattern may be used to help reduce the risk of the user experiencing leakage from the ostomy appliance. Additionally, determining the moisture pattern type and the operational state classification and/or the leakage pattern of the ostomy appliance may also be used to help reduce the risk of damage to the user's skin.

The present disclosure provides an efficient and easy to use ostomy appliance system with a high degree of comfort for the user.

The primary sensing region of the base plate and/or sensor assembly portion may be disposed in a primary angular space from a center point of the first adhesive layer. The primary angular space may span a primary angle in a range from 45 ° to 315 °, such as in a range from 45 ° to 135 °. The primary angle may depend on the number of angular sensing zones on the base plate and/or sensor assembly portion. For example, for a base plate and/or sensor assembly portion, for example, having two or more sensing zones, the primary angle may be about 180 ° ± 15 °. For a base plate and/or sensor assembly portion having, for example, two, three or more sensing regions, the primary angle may be about 120 ° ± 15 °. For a floor and/or sensor assembly portion having, for example, two, three, four or more sensing zones, the primary angle may be about 90 ° ± 15 °.

Alternatively or additionally, the primary sensing region may be arranged in a primary radial space from a central point of the first adhesive layer. The primary radial space may span a primary radius in the range from 10 to 50mm, such as in the range from 10 to 25mm, such as in the range from 19 to 20 mm. The primary radius may depend on the number of radial sensing zones on the base plate and/or sensor assembly portion.

The secondary sensing region may be arranged in a secondary angular space from a center point of the first adhesive layer. The secondary angular space may span secondary angles in a range from 45 ° to 315 °, such as in a range from 45 ° to 135 °. The secondary angle may depend on the number of angular sensing zones on the base plate and/or sensor assembly portion. For example, for a base plate and/or sensor assembly portion, for example, having two or more sensing zones, the secondary angle may be about 180 ° ± 15 °. For a floor and/or sensor assembly portion having, for example, two, three or more sensing zones, the secondary angle may be about 120 ° ± 15 °. For a floor and/or sensor assembly portion having, for example, two, three, four or more sensing zones, the secondary angle may be about 90 ° ± 15 °.

Alternatively or additionally, the secondary sensing zone may be arranged in a secondary radial space from a central point of the first adhesive layer. The secondary radial space may span a secondary radius in the range from 15 to 50mm, such as in the range from 20 to 30mm, such as in the range from 25 to 26 mm. The secondary radius may depend on the number of radial sensing zones on the base plate and/or sensor assembly portion. The secondary radius may be greater than the primary radius.

The plurality of electrodes may be configured to detect the presence of fluid proximally in a tertiary sensing zone. The tertiary sensing areas may be arranged in a tertiary angular space from a center point of the first adhesive layer.

The tertiary angle space may span tertiary angles in the range from 45 ° to 315 °, such as in the range from 45 ° to 180 °, for example in the range from 45 ° to 135 °. The tertiary angle may depend on the number of angular sensing zones on the base plate and/or sensor assembly portion. For example, for a base plate and/or sensor assembly portion having, for example, three or more sensing zones, the tertiary angle may be about 180 ° ± 15 °. For a base plate and/or sensor assembly portion having, for example, three or more sensing zones, the tertiary angle may be about 120 ° ± 15 °. For a base plate and/or sensor assembly portion having, for example, three, four or more sensing zones, the tertiary angle may be about 90 ° ± 15 °.

Alternatively or additionally, the tertiary sensing zones may be arranged in tertiary radial spaces from a center point of the first adhesive layer. The tertiary radial spaces may span tertiary radii in the range from 15 to 50mm, such as in the range from 25 to 50mm, such as in the range from 29 to 30 mm. The tertiary radius may depend on the number of radial sensing zones on the base plate and/or sensor assembly portion. The tertiary radius may be greater than the secondary radius and/or the primary radius.

The primary and secondary sensing zones may be separate sensing zones, i.e. non-overlapping. The primary and tertiary sensing zones may be separate sensing zones, i.e. non-overlapping. The secondary sensing zone and the tertiary sensing zone may be separate sensing zones, i.e. non-overlapping.

Primary, secondary, and/or tertiary sensing zones may cover electrodes embedded in the first adhesive layer, as well as leaky electrodes exposed to the ambient environment. Thus, the spread or absorption of moisture in the first adhesive layer may be detected in one or more sensing regions, thereby providing a determination of the direction of moisture spread in the first adhesive layer. Also, exudates spreading between the wearer's skin and the first adhesive layer may be determined by the exposed leakage electrode. These leak electrodes may be exposed through the sensor spot openings, as described below.

The first leakage electrode may include one or more primary first sensing portions arranged in the primary sensing region. The number of primary first sensing portions may range from 3 to 10, such as 4, 5, 6, or 7. The number of the first sensing parts may depend on a first-order angle and/or a radial distance of the first sensing parts from the center point. The first leakage electrode may include one or more tertiary first sensing portions arranged in the tertiary sensing region. The number of the three-stage first sensing portions may be in a range from 3 to 10, for example, 4, 5, 6, or 7. The number of the three-stage first sensing parts may depend on three-stage angles and/or radial distances of the three-stage first sensing parts from the center point.

The second leakage electrode includes one or more primary second sensing portions arranged in the primary sensing region. The number of primary second sensing portions may range from 3 to 10, such as 4, 5, 6, or 7. The number of the first-stage second sensing parts may depend on a first-stage angle and/or radial distance of the first-stage second sensing parts from the center point. The second leakage electrode includes one or more secondary second sensing portions arranged in the secondary sensing region. The number of secondary second sensing portions may range from 3 to 10, such as 4, 5, 6, or 7. The number of secondary second sensing portions may depend on the secondary angle and/or radial distance of the secondary second sensing portions from the center point.

The third leakage electrode may include one or more secondary third sensing portions arranged in the secondary sensing region. The number of secondary third sensing portions may range from 3 to 10, such as 4, 5, 6, or 7. The number of secondary third sensing portions may depend on the secondary angle and/or radial distance of the secondary third sensing portions from the center point. The third leakage electrode may include one or more tertiary third sensing portions arranged in the tertiary sensing region. The number of the three-stage third sensing portions may be in a range from 3 to 10, for example, 4, 5, 6, or 7. The number of the third sensing parts may depend on three-level angles and/or radial distances of the third sensing parts from the center point.

The first adhesive layer may have a plurality of sensor dot openings. The sensor dot opening of the first adhesive layer is configured to overlap with a portion (sensing portion) of the leak electrode, for example, to form a sensor dot. The sensing portion of the first leakage electrode may be exposed to the proximal side of the first adhesive layer via the first adhesive layer and/or the sensor spot opening in the masking element. The sensing portion of the second leakage electrode may be exposed to the proximal side of the first adhesive layer via the first adhesive layer and/or the sensor spot opening in the masking element. The sensing portion of the third leakage electrode may be exposed to the proximal side of the first adhesive layer via the first adhesive layer and/or the sensor spot opening in the masking element.

The distance between two adjacent sensor spot openings may be in the range from 1mm to 20 mm.

The sensor spot opening of the first adhesive layer may have a suitable shape and size to facilitate access to the leakage electrode from the proximal side of the first adhesive layer. The sensor dot openings of the first adhesive layer may have a circular or oval shape. The sensor dot openings of the first adhesive layer may have a rectangular or square shape, optionally with rounded corners.

The minimum extension of the sensor spot opening of the first adhesive layer may be at least 0.5mm, such as at least 1 mm. A sufficiently large minimum extension reduces the risk that the first adhesive layer closes the sensor spot opening, or at least partially or completely covers the sensing portion of the corresponding leakage electrode, due to the flow capacity of the material.

The maximum extension of the sensor spot opening of the first adhesive layer may be less than 20 mm.

Exemplary sensor spot openings of the first adhesive layer may have a minimum extent (e.g., measured radially from a center point) in a range from 1mm to 4mm, and/or a maximum extent (e.g., measured circumferentially about a center point) in a range from 2mm to 6 mm.

The sensor dot openings of the first adhesive layer may comprise primary sensor dot openings. The number of primary sensor point openings may depend on the primary angular and/or radial distance of the primary sensor point openings from the center point. In one or more exemplary base plates and/or sensor assembly portions, the number of primary sensor point openings is in the range of 5 to 20, such as in the range of 7 to 15. These primary sensor spot openings may include one or more primary first sensor spot openings configured to overlap a portion (sensing portion) of a leakage electrode and one or more primary second sensor spot openings configured to overlap a portion (sensing portion) of another leakage electrode different from the leakage electrode at least partially overlapping the primary first sensor spot openings.

The sensor dot openings of the first adhesive layer may comprise secondary sensor dot openings. The number of secondary sensor point openings may depend on the secondary angle and/or radial distance of the secondary sensor point openings from the center point. In one or more exemplary base plates and/or sensor assembly portions, the number of secondary sensor point openings is in the range of 5 to 20, such as in the range of 7 to 15. The secondary sensor spot openings may comprise one or more secondary first sensor spot openings configured to overlap a portion (sensing portion) of an electrode and one or more secondary second sensor spot openings configured to overlap a portion (sensing portion) of another electrode different from the electrode at least partially overlapping the secondary first sensor spot openings.

The sensor dot openings of the first adhesive layer may include three levels of sensor dot openings. The number of tertiary sensor point openings may depend on the tertiary angle and/or radial distance of the tertiary sensor point openings from the central point. In one or more exemplary base plates and/or sensor assembly portions, the number of tertiary sensor point openings is in the range of 5 to 20, such as in the range of 7 to 15. The tertiary sensor spot openings may include one or more tertiary first sensor spot openings configured to overlap a portion (sensing portion) of a (first) leakage electrode and one or more tertiary third sensor spot openings configured to overlap a portion (sensing portion) of another (third) leakage electrode different from the electrode at least partially overlapping the tertiary first sensor spot openings.

The first adhesive layer may have a substantially uniform thickness. The thickness of the first adhesive layer may be in the range from 0.1mm to 1.5mm, for example in the range from 0.2mm to 1.2mm, such as 0.8mm, or 1.0 mm.

The first adhesive layer may have a main thickness in a main portion of the first adhesive layer, e.g. in a main zone within a main radial distance or within a main radial distance from a centre point of the stoma opening. The main thickness may be in the range from 0.2mm to 1.5mm, such as about 1.0 mm. The main radial distance may be in the range from 20mm to 50mm, such as in the range from 25mm to 35mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondary portion of the first adhesive layer, e.g. in a secondary region outside or within a secondary radial distance from a centre point of the stoma opening. The minor thickness may be in the range from 0.2mm to 1.0mm, such as about 0.5 mm. The secondary radial distance may be in the range from 20mm to 50mm, such as in the range from 25mm to 35mm, e.g. 30 mm.

The base plate and/or the sensor assembly portion may include a second layer. The second layer may be an adhesive layer. The second layer may have a second radial extension which is greater than a first radial extension of the first adhesive layer at least in a first angular range of the base plate and/or the sensor assembly portion. Thus, a portion of the proximal surface of the second layer may be configured to attach to a skin surface of a user. The portion of the proximal surface of the second layer that is configured to attach to the skin surface of the user, also referred to as the skin attachment surface of the second adhesive layer. The second layer may have a stoma opening with a centre point, such as the second layer stoma opening and/or the second adhesive stoma opening.

The second adhesive layer may be made of a second composition. The second composition may include one or more of polyisobutylene and/or styrene-isoprene-styrene. The second composition may comprise one or more hydrocolloids. The second composition may comprise one or more water soluble or water swellable hydrocolloids.

The second composition may be a pressure sensitive adhesive composition suitable for medical purposes comprising a rubbery elastomeric substrate and one or more water soluble or water swellable hydrocolloids. The second composition may include one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of polybutene and the absorption properties of hydrocolloid renders the second composition suitable for use in ostomy appliances. The styrene copolymer may be, for example, a styrene-butadiene-styrene block copolymer, or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are employed. The amount of styrene block copolymer may be from 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is Polyisobutylene (PIB). Hydrocolloids suitable for incorporation in the second composition are selected from natural hydrocolloids, semi-synthetic hydrocolloids, and synthetic hydrocolloids. The second composition may comprise 20% to 60% hydrocolloid. A preferred hydrocolloid is carboxymethyl cellulose (CMC). The second composition may optionally comprise other components such as fillers, tackifiers, plasticizers, and other additives.

Different ratios of inclusions may alter the properties of the first and/or second adhesive layers. The second adhesive layer and the first adhesive layer may have different properties. The second adhesive layer (second composition) and the first adhesive layer (first composition) may have different ratios of polyisobutylene, styrene-isoprene-styrene, and/or hydrocolloid. For example, the second adhesive layer may provide a stronger attachment to the skin than the first adhesive layer provides. Alternatively or additionally, the second adhesive layer may be thinner than the first adhesive layer. Alternatively or in addition, the second adhesive layer may be less water and/or sweat absorbent than the first adhesive layer. Alternatively or in addition, the second adhesive layer may be less moldable than the first adhesive layer. The second adhesive layer can provide a second leakage barrier.

The second layer may have a substantially uniform thickness. The thickness of the second layer may be in the range from 0.1mm to 1.5mm, for example in the range from 0.2mm to 1.0mm, such as 0.5mm, 0.6mm, or 0.7 mm.

In the present disclosure, the reference of the ground electrode (or the fourth electrode portion of the ground electrode) is the reference of the first leakage electrode. Thus, throughout this disclosure, the first leakage electrode is also referred to or denoted as the ground electrode. In other words, the ground electrode functions as the first leak electrode.

In the present disclosure, the reference of the fourth electrode is the reference of the second leakage electrode. Thus, the second leakage electrode is also referred to or denoted as the fourth electrode throughout this disclosure. In other words, the fourth electrode functions as the second leak electrode.

In the present disclosure, the reference of the fifth electrode is the reference of the third leak electrode. Thus, the third leakage electrode is also referred to or denoted as the fifth electrode throughout this disclosure. In other words, the fifth electrode functions as the third leak electrode.

The base plate and/or the sensor assembly portion may comprise one or more electrodes, such as a plurality of electrodes, such as two, three, four, five, six, seven, or more electrodes. The sensor assembly portion may be applied to the base plate, for example, such that the base plate has the one or more electrodes.

These electrodes, e.g. some or all of the electrodes, may be arranged between the first adhesive layer and the second adhesive layer. The electrodes may be arranged in an electrode assembly, e.g. an electrode layer. The electrode includes a connection portion for connecting the electrode to other components and/or interface terminals/terminal elements. The electrodes may include one or more conductive portions and/or one or more sensing portions. The conductor portion may be considered as the portion of the electrode connecting two or more sensing portions, and/or connecting the sensing portions of the respective electrodes with the connection portion. The sensing portion may be considered to be that portion of the electrode which is suitable for sensing, for example, liquid (such as liquid contents), and/or effluent (such as effluent resulting from a leak or an impending leak). The sensing portion may be adapted to sense, for example, by its shape, which is potentially circular, oval, or rectangular. Thus, the conductor portion may conduct a signal originating from the sensing portion. The electrode may comprise alternating conductor portions and sensing portions. The electrode assembly may be disposed between the first adhesive layer and the second adhesive layer. The base plate and/or the sensor assembly portion, e.g., the electrode assembly, may include a first electrode, a second electrode, and optionally a third electrode. The base plate and/or the sensor assembly part, e.g. the electrode assembly, may comprise a fourth electrode and/or a fifth electrode. The base plate and/or the sensor assembly portion, e.g., the electrode assembly, optionally includes a sixth electrode. The base plate and/or the sensor assembly portion, e.g., the electrode assembly, may include a ground electrode. The ground electrode may include a first electrode portion. The first electrode portion of the ground electrode may form a ground or reference for the first electrode. The ground electrode may include a second electrode portion. The second electrode portion of the ground electrode may form a ground or reference for the second electrode. The ground electrode may include a third electrode portion. The third electrode portion of the ground electrode may form a ground or reference for the third electrode. The ground electrode may include a fourth electrode portion. The fourth electrode portion of the ground electrode may form a ground or reference for the fourth electrode and/or the fifth electrode. The ground electrode may be configured as or form a (common) reference electrode for some or all of the other electrodes in the electrode assembly.

The electrodes are electrically conductive and may include one or more of the following: metallic materials (e.g., silver, copper, gold, titanium, aluminum, stainless steel), ceramic materials (e.g., ITO), polymeric materials (e.g., PEDOT, PANI, PPy), and carbonaceous materials (e.g., carbon black, carbon nanotubes, carbon fibers, graphene, graphite).

The ground electrode may include a first electrode portion and a second electrode portion, the first electrode portion forming a ground of the first electrode, and the second electrode portion forming a ground of the second electrode. The first electrode portion may form a closed loop.

Two electrodes in the electrode assembly may form a sensor. The first and second leakage electrodes may form a primary leakage sensor or a primary pair of leakage electrodes for detecting the presence of fluid in a primary sensing zone on the proximal side of the first adhesive layer. The second and third leakage electrodes may form a secondary leakage sensor or a secondary leakage electrode pair for detecting the presence of fluid in a secondary sensing zone on the proximal side of the first adhesive layer. The first and third leakage electrodes may form a tertiary leakage sensor or a tertiary leakage electrode pair for detecting the presence of fluid in a tertiary sensing zone on the proximal side of the first adhesive layer.

The electrode may comprise one or more sensing portions, i.e. the portion(s) of the electrode used for sensing. The first electrode may comprise a first sensing portion contacting the first adhesive layer and arranged at least partially annularly around the stoma opening. The first electrode may include a first conductor portion insulated from the first adhesive layer, for example, by a masking element disposed between the first conductor portion and the first adhesive layer. The first sensing portion may extend at least 270 degrees around the stoma opening, such as at least 300 degrees around the stoma opening. The first sensing portion of the first electrode may be arranged at a first ground distance from the first electrode portion of the ground electrode. The first ground distance may be less than 5mm, such as less than 3mm, for example about 1.0 mm.

The second electrode may include a second sensing part contacting the first adhesive layer. The second sensing portion may be at least partially annularly arranged around the stoma opening. The second sensing portion may extend at least 270 degrees around the stoma opening, such as at least 300 degrees around the stoma opening. The second sensing portion of the second electrode may be disposed at a second ground distance from the second electrode portion of the ground electrode. The second ground distance may be less than 5mm, such as less than 3mm, for example about 1.0 mm.

The first sensing portion may be arranged at a first radial distance from the center point, and the second sensing portion may be arranged at a second radial distance from the center point. The second radial distance may be greater than the first radial distance. The second electrode may include a second conductor portion insulated from the first adhesive layer, for example, by a masking element disposed between the second conductor portion and the first adhesive layer. The first radial distance may vary according to an angular position with respect to a zero direction of the center point. The second radial distance may vary according to an angular position with respect to a zero direction of the center point. The zero direction may be defined as the vertically upward direction when the base plate and/or the sensor assembly portion is positioned on an upright user in its intended wearing position.

The first radial distance may be in the range from 5mm to 40mm, such as in the range from 10mm to 25mm, for example about 14 mm. The second radial distance may be in the range from 10mm to 50mm, such as in the range from 10mm to 25mm, for example about 18 mm.

The base plate and/or the sensor assembly portion may include a third electrode including a third connection portion. The ground electrode may form a ground of the third electrode. The ground electrode may comprise a third electrode portion forming a ground for the third electrode. The third electrode may include a third conductor portion insulated from the first adhesive layer, for example, by a masking element disposed between the third conductor portion and the first adhesive layer. The third electrode may include a third sensing part contacting the first adhesive layer. The third sensing portion may be at least partially annularly arranged around the stoma opening. The third sensing portion may be arranged at a third radial distance from the center point. The third radial distance may be greater than the first radial distance, and/or greater than the second radial distance. The third radial distance may be in the range from 15mm to 50mm, such as in the range from 20mm to 30mm, for example about 26 mm. The third sensing portion may extend at least 270 degrees around the stoma opening, such as at least 300 degrees around the stoma opening. The third sensing portion of the third electrode may be arranged at a third ground distance from the third electrode portion of the ground electrode. The third ground distance may be less than 5mm, such as less than 3mm, for example about 1.0 mm. In case the first electrode is cut or otherwise damaged during e.g. the preparation of the base plate and/or the sensor component part, the base plate and/or the sensor component part with the ground electrode, the first electrode, the second electrode and the third electrode still allows to obtain a base plate and/or a sensor component part without failures.

The bottom plate and/or the sensor assembly portion comprises a second leakage electrode, also referred to as fourth electrode, which comprises a fourth connection portion. The ground electrode (first leakage electrode) may form a ground of the fourth electrode. The ground electrode may comprise a fourth electrode portion forming a ground for the fourth electrode. The fourth electrode may comprise one or more fourth sensing portions, such as at least five fourth sensing portions. These fourth sensing portions may be distributed around the stoma opening or a central point thereof. These fourth sensing portions may be arranged at respective fourth radial distances from the centre point. The fourth radial distance(s) may be greater than the third radial distance. The fourth radial distance(s) may be in the range from 25mm to 50mm, such as about 30mm

The base plate and/or the sensor assembly portion may include a fifth electrode including a fifth connection portion. The ground electrode may form a ground of the fifth electrode. The ground electrode may comprise a fifth electrode portion forming the ground of the fifth electrode. The fifth electrode may include one or more fifth sensing parts, such as at least five fifth sensing parts. The fifth sensing parts may be distributed around the stoma opening or a central point thereof. The fifth sensing portions may be arranged at respective fifth radial distances from the center point. The fifth radial distance may be greater than the third radial distance. The fifth radial distance may be greater than the fourth radial distance. The fifth radial distance(s) may be in the range from 25mm to 50mm, such as about 30 mm.

The first electrode may form an open loop. The second electrode may form an open loop, and/or the third electrode may form an open loop. The fourth electrode may form an open loop. The fifth electrode may form an open loop. The open loop electrode(s) enable the electrodes to be arranged in few or a single electrode layer.

The base plate and/or the sensor assembly portion may comprise a second adhesive layer, wherein the plurality of electrodes is arranged between the first adhesive layer and the second adhesive layer.

The electrode assembly may include a support layer, also referred to as a support film. One or more electrodes may be formed, e.g., printed, on the proximal side of the support layer. One or more electrodes may be formed, e.g. printed, on the distal side of the support layer. Thus, one or more electrodes may be arranged between the support layer and the first adhesive layer. The electrode assembly, such as the support layer of the electrode assembly, may have a stoma opening with a central point, such as the electrode assembly stoma opening and/or the support layer stoma opening.

The support layer may comprise a polymeric material (e.g., polyurethane, PTFE, PVDF), and/or a ceramic material (e.g., alumina, silica). In one or more exemplary chassis and/or sensor assembly sections, the support layer is made of Thermoplastic Polyurethane (TPU). The support layer material may include one or more of the following: polyesters, thermoplastic elastomers (TPEs), polyamides, polyimides, Ethylene Vinyl Acetate (EVA), polyureas, and silicones.

Exemplary thermoplastic elastomers for the support layer are styrene block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulcanizates (TPV, TPE-v), Thermoplastic Polyurethanes (TPU), thermoplastic copolyesters (TPC, TPE-E) and thermoplastic polyamides (TPA, TPE-A).

The base plate and/or the sensor assembly portion, such as the electrode assembly, may include a masking element configured to insulate at least a portion of the electrode from the first adhesive layer of the base plate and/or the sensor assembly portion. The masking element may comprise one or more, such as a plurality of sensor spot openings. The sensor spot openings may comprise primary sensor spot openings, and/or secondary sensor spot openings. The sensor spot opening may comprise a tertiary sensor spot opening(s). The sensor spot opening may comprise a quaternary sensor spot opening(s). The sensor spot opening of the masking element overlaps with at least one electrode of the electrode assembly, e.g. to form a sensor spot, when seen in the axial direction. For example, the primary sensor dot opening may overlap with a portion of the ground electrode (sensing portion), and/or a portion of the fourth electrode (sensing portion). The secondary sensor spot opening may overlap with a portion of the fourth electrode (sensing portion), and/or a portion of the fifth electrode (sensing portion). The tertiary sensor spot opening may overlap with a portion of the fifth electrode (sensing portion), and/or a portion of the ground electrode (sensing portion).

The masking element may comprise one or more, such as a plurality of terminal openings. The terminal opening may overlap with one or more connecting portions of the electrode. In one or more exemplary base plates, each terminal opening overlaps a single connection portion of an electrode.

The masking element may include a polymeric material (e.g., polyurethane, PTFE, PVDF), and/or a ceramic material (e.g., alumina, silica). In one or more exemplary backplanes and/or sensor assembly sections, the masking element comprises or is made of Thermoplastic Polyurethane (TPU). In one or more exemplary backplanes and/or sensor assembly portions, the masking element comprises, or is made of, polyester. The masking element material may include one or more of the following: polyesters, thermoplastic elastomers (TPEs), polyamides, polyimides, Ethylene Vinyl Acetate (EVA), polyureas, and silicones.

Exemplary thermoplastic elastomers for the masking element are styrene block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulcanizates (TPV, TPE-v), Thermoplastic Polyurethanes (TPU), thermoplastic copolyesters (TPC, TPE-E) and thermoplastic polyamides (TPA, TPE-A).

The base plate and/or the sensor assembly portion may comprise a first intermediate element. The first intermediate element may be arranged between the electrode/electrode layer and the first adhesive layer, and/or between the second layer and the first adhesive layer. The first intermediate layer may be made of an insulating material.

The base plate and/or the sensor assembly portion may include a release liner. Release liners are protective layers that protect the adhesive layer(s) during transport and storage, and are peeled off by the user prior to application of the base sheet to the skin. The release liner may have a stoma opening with a central point, such as a release liner stoma opening.

The base plate and/or the sensor assembly portion may include a top layer. The top layer is a protective layer protecting the adhesive layer(s) from external strains and stresses when the ostomy appliance is worn by the user. These electrodes, e.g. some or all of the electrodes, may be arranged between the first adhesive layer and the top layer. The top layer may have a stoma opening with a centre point, such as a top layer stoma opening. The thickness of the top layer may be in the range from 0.01mm to 1.0mm, for example in the range from 0.02mm to 0.2mm, such as 0.04 mm. The top layer may have a stoma opening with a central point.

The backplane and/or the sensor assembly portion may include a monitor interface. The monitor interface may be configured for electrically and/or mechanically connecting the ostomy appliance (base plate and/or sensor assembly part) to the monitoring device. The monitor interface may be configured for wirelessly connecting the ostomy appliance (base plate and/or sensor assembly part) to the monitoring device. Thus, the monitor interface of the base plate and/or the sensor assembly part may be configured for electrically and/or mechanically coupling the ostomy appliance and the monitoring device.

The monitor interface of the base plate and/or the sensor assembly portion may comprise a coupling portion, for example as part of a first connector of the monitor interface, for forming a mechanical connection, such as a releasable coupling, between the monitoring device and the base plate and/or the sensor assembly portion. The coupling portion may be configured to engage with a coupling portion of a monitoring device to releasably couple the monitoring device to the floor and/or the sensor assembly portion.

The monitor interface of the backplane and/or the sensor assembly portion may include a plurality of terminals, such as two, three, four, five, six, seven, or more terminals, for example, as part of the first connector of the monitor interface for forming electrical connections with corresponding terminals of the monitoring device. The monitor interface may include a ground terminal element forming a ground terminal. The monitor interface may include a first terminal element forming a first terminal, a second terminal element forming a second terminal, and optionally a third terminal element forming a third terminal. The monitor interface may include a fourth terminal element forming a fourth terminal, and/or a fifth terminal element forming a fifth terminal. The monitor interface optionally includes a sixth terminal element forming a sixth terminal. The terminal elements of the monitor interface may contact the base plate and/or corresponding electrodes (connections) of the sensor assembly portion, such as an electrode assembly. The first intermediate member may be arranged between the terminal member and the first adhesive layer. The first intermediate element may cover or overlap the terminal element(s) of the base plate and/or the sensor assembly part, as seen in the axial direction. Thus, the first adhesive layer may be protected or subjected to more evenly distributed mechanical stress from the base plate and/or the terminal elements of the sensor assembly portion, thereby reducing the risk of the terminal elements piercing or otherwise damaging the first adhesive layer. The first intermediate member may protect the first adhesive layer from the base plate and/or the terminal member of the sensor assembly portion, or mechanically and/or electrically isolate the first adhesive layer from the terminal member.

A terminal element, such as a ground terminal element, a first terminal element, a second terminal element, a third terminal element, a fourth terminal element, a fifth terminal element, and/or a sixth terminal element, may include a distal end and a proximal end. The terminal elements, such as a ground terminal element, a first terminal element, a second terminal element, a third terminal element, a fourth terminal element, a fifth terminal element, and/or a sixth terminal element, may include a distal portion, a central portion, and/or a proximal portion. The distal portion may be between the distal end and the central portion. The proximal portion may be between the proximal end and the central portion. The proximal end/portion of the terminal element may contact the connection portion of the electrode. The terminal elements, such as a ground terminal element, a first terminal element, a second terminal element, a third terminal element, a fourth terminal element, a fifth terminal element, and/or a sixth terminal element, may be gold-plated copper.

The base plate may comprise a coupling ring or other coupling member for coupling the ostomy bag to the base plate (two-piece ostomy appliance). The center point may be defined as the center of the coupling ring.

The base plate and/or the sensor assembly portion has a stoma opening with a central point. The stoma opening of the base plate and/or the sensor component portion may be collectively formed by the stoma opening(s) of the layers of the base plate and/or the sensor component portion, such as the top layer, the first adhesive layer, the second layer and/or the sensor component portion. The stoma opening(s) of the base plate and/or a layer of the sensor component part (e.g., the top layer, the first adhesive layer, the second layer, and/or the sensor component part) may be aligned to form the stoma opening of the base plate and/or the sensor component part. The stoma opening may be a through passage of the base plate and/or the sensor assembly portion. The stoma opening may be arranged substantially in the center of the base plate and/or the sensor assembly portion. The stoma opening(s) of the floor and/or the layers of the sensor assembly portion may be arranged substantially in the center of the respective layer. The stoma opening may be configured to receive a stoma of a user and/or the stoma opening may be configured to allow discharge from the stoma to pass through the stoma opening into an ostomy pouch attached to the base plate. For example, the stoma opening may be configured to allow discharge to flow from a proximal side of the base plate and/or sensor assembly portion to a distal side of the base plate and/or sensor assembly portion. The size and/or shape of the stoma opening may typically be adjusted by the user or a nurse to fit the stoma of the user prior to application of the ostomy appliance. In one or more exemplary base plates, the user forms the stoma opening during preparation of the base plate for application.

The monitoring device includes a processor and one or more interfaces, such as a first interface and/or a second interface. The monitoring device may comprise a memory for storing ostomy data.

In one or more example monitoring devices, a processor is configured to apply a processing scheme, a first interface is connected to the processor and memory, and the first interface is configured to collect ostomy data from a base plate and/or a sensor assembly portion coupled to the first interface. The ostomy data may comprise one or more, such as all, of the following: first ostomy data from a first electrode pair of the base plate and/or the sensor assembly portion, second ostomy data from a second electrode pair of the base plate and/or the sensor assembly portion, and third ostomy data from a third electrode pair of the base plate and/or the sensor assembly portion. The second interface is connected to the processor. The application processing scheme may include one or more of: obtaining first parameter data based on the first ostomy data; obtaining second parameter data based on the second ostomy data; and obtaining third parameter data based on the third ostomy data. Applying the processing scheme may include: determining an operational state of a base plate and/or a sensor assembly part of an ostomy appliance based on one or more, such as all, of the first parameter data, the second parameter data and the third parameter data. The operational state may be indicative of the degree of radial corrosion of the base plate, such as the first adhesive layer, and/or the risk of serious leakage of the ostomy appliance. The monitoring device is configured for: in accordance with a determination that the operating state is a first operating state, sending a first monitor signal via the second interface, the first monitor signal containing monitor data indicative of the first operating state of the backplane and/or the sensor assembly portion; and/or in accordance with a determination that the operating state is the second operating state, sending a second monitor signal via the second interface, the second monitor signal containing monitor data indicative of the second operating state of the backplane and/or the sensor assembly portion.

In one or more exemplary monitoring devices, the first operating state of the base plate and/or the sensor assembly portion corresponds to the following: the first adhesive layer of the base plate and/or the sensor assembly portion experiences a first degree of radial erosion, e.g., the first adhesive layer erodes to a first radial distance of the first electrode pair but does not erode to a second radial distance of the second electrode pair.

In one or more exemplary monitoring devices, the second operating state of the base plate and/or the sensor assembly portion corresponds to the following: the first adhesive layer of the base plate and/or the sensor assembly portion experiences a second degree of radial erosion, e.g., the first adhesive layer erodes to a second radial distance of the second electrode pair, but does not erode to a third radial distance of the third electrode pair.

Obtaining the first parameter data based on the first ostomy data may comprise determining one or more first parameters based on the first ostomy data. Obtaining second parameter data based on the second ostomy data may comprise determining one or more second parameters based on the second ostomy data. Obtaining third parameter data based on the third ostomy data may comprise determining one or more third parameters based on the third ostomy data. In one or more example monitoring devices, determining the operating state may be based on one or more first parameters of the first parameter data, such as a first primary parameter and/or a first secondary parameter. In one or more exemplary monitoring devices, determining the operating state may be based on one or more second parameters of the second parameter data, such as a second level one parameter and/or a second level two parameter. In one or more exemplary monitoring devices, determining the operating state may be based on one or more third parameters of the third parameter data, such as a third level parameter and/or a third level parameter. In one or more exemplary monitoring devices, determining the operating state may be based on one or more fourth parameters of the fourth parameter data, such as a fourth level parameter and/or a fourth level parameter.

The first parameter data, the second parameter data, and the third parameter data may indicate resistances between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.

The first parameter data, the second parameter data, and the third parameter data may indicate rates of resistance change between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.

In one or more example monitoring devices, determining the operating state of the baseplate and/or the sensor assembly portion is based on a first set of metrics of the first parameter data and/or the second parameter data, wherein the operating state is determined to be the first operating state if the first set of metrics is satisfied. The first set of metrics may include one or more first metrics based on one or more of the first parametric data, the second parametric data, and the third parametric data. The first set of metrics may include a first primary metric based on the first parametric data. The first set of metrics may include a first secondary metric based on the second parameter data. The first set of metrics may include a first tertiary metric based on the third parametric data.

In one or more example monitoring devices, determining an operating state of a floor and/or sensor assembly portion may be based on a first set of thresholds including one or more first thresholds. The first set of thresholds may comprise one or more thresholds to be applied in the first set of metrics, for example. The first set of thresholds may include a first primary level threshold. The first set of thresholds may include a first secondary threshold. The first set of thresholds may include a first tertiary threshold.

The first set of metrics may be given by:

(P_1_1<TH_1_1)，

(P _2_1> TH _1_2), and

(P_3_1>TH_1_3)，

wherein P _1_1 is a first primary parameter based on the first parameter data, TH _1_1 is a first primary threshold, P _2_1 is a second primary parameter based on the second parameter data, TH _1_2 is a first secondary threshold, P _3_1 is a third primary parameter based on the third parameter data, and TH _1_3 is a first tertiary threshold, and wherein the first operating state is indicative of a low degree of radial erosion of the base plate and/or the sensor assembly portion. These first thresholds (TH _1_1, TH _1_2, and TH _1_3) may be the same or different, for example depending on the electrode configuration of the base plate and/or the sensor component part. The first tertiary index (P _3_1< TH _1_3) may be omitted in the first index set.

The first primary parameter P _1_1 may indicate a resistance between the base plate and/or the first electrode pair of the sensor assembly portion (first electrode and first electrode portion of the ground electrode).

The second primary parameter may be indicative of a resistance between the backplane and/or a second electrode pair of the sensor assembly portion (second electrode and a second electrode portion of the ground electrode).

The third primary parameter may be indicative of a resistance between the backplane and/or a third electrode pair of the sensor assembly portion (third electrode and a third electrode portion of the ground electrode).

In one or more example monitoring devices, determining the operating state of the baseplate and/or the sensor assembly portion is based on a second set of metrics of the second parameter data and/or the third parameter data, wherein the operating state is determined to be the second operating state if the second set of metrics is satisfied. The second set of metrics may be based on the first parameter data.

The second set of metrics may include one or more second metrics based on one or more of the first parameter data, the second parameter data, and the third parameter data. The second set of metrics may include a second primary metric based on the first parametric data. The second set of metrics may include a second level metric based on the second parametric data. The second set of metrics may include a second tertiary metric based on the third parametric data.

In one or more example monitoring devices, determining an operating state of the floor and/or the sensor assembly portion is based on a second set of thresholds including one or more second thresholds. The second set of thresholds may include one or more thresholds to be applied in the second set of indices, for example. The second set of thresholds may include a second level threshold. The second set of thresholds may include a second level threshold. The second set of thresholds may include a second set of tertiary thresholds.

The second set of metrics may be given by:

(P_1_1<TH_2_1)，

(P _2_1< TH _2_2), and

(P_3_1>TH_2_3)

wherein P _1_1 is a first primary parameter based on the first parameter data and indicates a resistance between the first electrode pair, TH _2_1 is a second primary threshold, P _2_1 is a second primary parameter based on the second parameter data and indicates a resistance between the second electrode pair, TH _2_2 is a second secondary threshold, P _3_1 is a third primary parameter based on the third parameter data and indicates a resistance between the third electrode pair, TH _2_3 is a second tertiary threshold, and wherein the second operating state indicates a moderate degree of radial erosion of the base plate and/or the sensor assembly portion. The second threshold values (TH _2_1, TH _2_2, and TH _2_3) may be the same or different, for example, depending on the electrode configuration of the base plate and/or the sensor component part. The second level indicator (P _1_1< TH _2_1) and/or the second level indicator (P _3_1> TH _2_3) may be omitted in the second set of indicators.

In one or more example monitoring devices, determining the operational state of the base plate and/or the sensor assembly portion is a default set of indicators based on the first parameter data, wherein if the default set of indicators is met, the operational state is determined to be a default operational state, and in accordance with the determination that the operational state is the default operational state, transmitting a default monitor signal containing monitor data indicative of the default operational state of the ostomy appliance.

The default set of metrics may be given by:

(P_1_1>TH_D_1)，

(P _2_1> TH _ D _2), and

(P_3_1>TH_D_3)

wherein P _1_1 is a first primary parameter based on the first parameter data and indicates a resistance between the first electrode pair, TH _ D _1 is a default primary threshold, P _2_1 is a second primary parameter based on the second parameter data and indicates a resistance between the second electrode pair, TH _ D _2 is a default secondary threshold, P _3_1 is a third primary parameter based on the third parameter data and indicates a resistance between the third electrode pair, TH _ D _3 is a default tertiary threshold, and wherein the default operating state indicates a very low or zero degree of radial erosion of the base plate and/or the sensor assembly portion. The default thresholds (TH _ D _1, TH _ D _2 and TH _ D _3) may be the same or different, e.g. depending on the electrode configuration of the base plate and/or the sensor assembly part.

In one or more example monitoring devices, determining the operational state of the base plate and/or the sensor assembly portion is based on a third set of indicators of third parameter data, wherein if the third set of indicators is met, determining the operational state to be the third operational state, and in accordance with the determination that the operational state is the third operational state, transmitting a third monitor signal comprising monitor data indicative of the third operational state of the ostomy appliance.

In one or more exemplary monitoring devices, the third operational state of the base plate and/or the sensor assembly portion corresponds to the following: the first adhesive layer of the base plate and/or the sensor assembly portion experiences a third degree of radial erosion, e.g., the first adhesive layer erodes to a third radial distance of the third electrode pair.

The third set of metrics may be given by:

(P_1_1<TH_3_1)，

(P _2_1< TH _3_2), and

(P_3_1<TH_3_3)

wherein P _1_1 is a first primary parameter based on the first parameter data and indicates a resistance between the first electrode pair, TH _3_1 is a third primary threshold, P _2_1 is a second primary parameter based on the second parameter data and indicates a resistance between the second electrode pair, TH _3_2 is a third secondary threshold, P _3_1 is a third primary parameter based on the third parameter data and indicates a resistance between the third electrode pair, TH _3_3 is a third tertiary threshold, and wherein the third operating state indicates a high degree of radial corrosion of the base plate and/or the sensor assembly portion. The third threshold values (TH _3_1, TH _3_2 and TH _3_3) may be the same or different, for example depending on the electrode configuration of the base plate and/or the sensor component part. The third level indicator (P _1_1< TH _3_1) and/or the third level indicator (P _2_1< TH _3_2) may be omitted in the third set of indicators.

In one or more exemplary monitoring devices, the ostomy data comprises fourth ostomy data from a fourth electrode pair (first leakage electrode and second leakage electrode) of the base plate and/or the sensor assembly portion. Applying the treatment protocol may comprise obtaining fourth parameter data based on the fourth ostomy data and determining an operational state of the base plate and/or the sensor assembly part of the ostomy appliance based on the fourth parameter data. The monitoring device may be configured to transmit a fourth monitor signal comprising monitor data indicative of a fourth operational state of the ostomy appliance in dependence of the determination of the operational state as the fourth operational state.

In one or more exemplary monitoring devices, the fourth operational state of the base plate and/or the sensor assembly portion corresponds to the following: the fourth electrode pair detects fluid, such as discharge, between the distal surface of the first adhesive layer and the skin of the user at a fourth radial distance and thus there is a high risk of leakage from the ostomy appliance in the fourth operational state.

The fourth set of metrics may be given by:

(P_4_1<TH_4_4)

wherein P _4_1 is a fourth primary parameter based on the fourth parameter data and indicative of the resistance between the fourth electrode pair and TH _4_4 is a fourth quaternary threshold, and wherein the fourth operational state is indicative of a high risk of leakage from the ostomy appliance.

In one or more exemplary monitoring devices, the ostomy data includes leakage ostomy data from one or more electrode pairs of the leakage electrodes of the base plate and/or the sensor assembly portion. The leakage ostomy data may comprise, for example, primary leakage ostomy data from the first leakage electrode and the second leakage electrode. The leakage ostomy data may comprise, for example, secondary leakage ostomy data from the second leakage electrode and the third leakage electrode. The leakage ostomy data may comprise, for example, tertiary leakage ostomy data from the first leakage electrode and the third leakage electrode.

Applying the processing scheme may comprise obtaining primary leakage parameter data based on primary leakage ostomy data of the leakage ostomy data, and determining an operational state of a base plate and/or a sensor assembly part of the ostomy appliance based on the primary leakage parameter data. The monitoring device may be configured to transmit a primary leakage monitor signal comprising monitor data indicative of a primary leakage operational state of the ostomy appliance in dependence on the determination of the operational state as a primary leakage operational state.

In one or more exemplary monitoring devices, the primary leak operating state of the base plate and/or the sensor assembly portion corresponds to the following: the first leakage and second leakage electrodes detect fluid, such as discharge, between the distal surface of the first adhesive layer and the skin of the user in the primary sensing zone and thus there is a high risk of leakage from the ostomy appliance in the primary leakage operating state. The primary leak monitor signal may indicate a high risk of leakage in the primary sensing zone.

The set of primary leakage indicators may be given by:

(P_PL<TH_PL)

where P _ P L is a primary leakage parameter based on primary leakage parameter data and is indicative of a resistance between a first leakage electrode and a second leakage electrode, and TH _ P L is a primary leakage threshold.

Applying the treatment scheme may comprise obtaining secondary leakage parameter data based on secondary leakage ostomy data of the leakage ostomy data, and determining an operational state of a base plate and/or a sensor assembly part of the ostomy appliance based on the secondary leakage parameter data. The monitoring device may be configured to transmit a secondary leakage monitor signal comprising monitor data indicative of a secondary leakage operating state of the ostomy appliance in dependence on the determination of the operating state as a secondary leakage operating state.

In one or more exemplary monitoring devices, the secondary leak operating state of the baseplate and/or the sensor assembly portion corresponds to the following: the second and third leakage electrodes detect fluid, such as effluent, in the secondary sensing zone between the distal surface of the first adhesive layer and the user's skin, and thus there is a high risk of leakage from the ostomy appliance in the secondary leakage operating state. The secondary leakage monitor signal may indicate a high risk of leakage in the secondary sensing zone.

The set of secondary leakage indicators may be given by:

(P_SL<TH_SL)

the secondary leakage parameter may be indicative of a resistance between the second leakage electrode and the third leakage electrode, see, e.g., fig. 11, the secondary leakage parameter may be indicative of a resistance between the first leakage electrode and the third leakage electrode, see, e.g., fig. 12 TH S L is a secondary leakage threshold, and the secondary leakage operational state is indicative of a high risk of leakage from a secondary sensing region of the ostomy appliance.

Applying the treatment scheme may comprise obtaining tertiary leakage parameter data based on tertiary leakage ostomy data of the leakage ostomy data, and determining an operational state of a base plate and/or a sensor assembly part of the ostomy appliance based on the tertiary leakage parameter data. The monitoring device may be configured to transmit a tertiary leakage monitor signal comprising monitor data indicative of a tertiary leakage operating state of the ostomy appliance in dependence on the determination of the operating state as a tertiary leakage operating state.

In one or more exemplary monitoring devices, the three-level leak operating state of the base plate and/or the sensor assembly portion corresponds to the following: the first and third leakage electrodes detect fluid, such as discharge, between the distal surface of the first adhesive layer and the skin of the user in the tertiary sensing zone and there is therefore a high risk of leakage from the ostomy appliance in the tertiary leakage operating state. The tertiary leakage monitor signal may indicate a high risk of leakage in the tertiary sensing zone.

The tertiary leakage index set may be given by:

(P_TL<TH_TL)

wherein P _ T L is a tertiary leakage parameter based on tertiary leakage parameter data and is indicative of a resistance between the first leakage electrode and the third leakage electrode, TH _ T L is a tertiary leakage threshold, and wherein the tertiary leakage operational state is indicative of a high risk of leakage from a tertiary sensing zone of the ostomy appliance.

The primary, secondary, and tertiary leakage thresholds may be the same or may be different.

The monitoring device comprises a monitoring device housing, optionally made of a plastic material. The monitoring device housing may be an elongated housing having a first end and a second end. The monitoring device housing may have a length or maximum extension along the longitudinal axis in the range from 1cm to 15 cm. The monitoring device housing may have a width or maximum extension perpendicular to the longitudinal axis in the range from 0.5cm to 3 cm. The monitoring device housing may be curvilinear. Additionally or alternatively, the monitoring device may be rigid or flexible.

The monitoring device includes a first interface. The first interface may be configured to electrically and/or mechanically connect the monitoring device to an appliance interface of an ostomy appliance. Thus, the appliance interface is configured for electrically and/or mechanically coupling the monitoring device to the ostomy appliance. The first interface may be configured as an accessory device interface for electrically and/or mechanically connecting the monitoring device to an accessory device, such as a docking station. The first interface may be configured for coupling to a docking station of an ostomy system, for example to charge the monitoring device, and/or to enable data transfer between the monitoring device and the docking station.

The first interface of the monitoring device may comprise a plurality of terminals, such as two, three, four, five, six, seven, or more terminals, to form an electrical connection with respective terminals and/or electrodes of the ostomy appliance. One or more terminals of the first interface may be configured to form an electrical connection with an accessory device, such as with corresponding terminals of a docking station. The first interface may include a ground terminal. The first interface may comprise a first terminal, a second terminal and optionally a third terminal. The first interface may comprise a fourth terminal and/or a fifth terminal. The first interface optionally includes a sixth terminal. In one or more exemplary monitoring devices, the first interface has M terminals, where M is an integer in the range from 4 to 8.

The first interface of the monitoring device may comprise a coupling to form a mechanical connection, such as a releasable coupling, between the monitoring device and the base plate and/or the sensor assembly portion. The coupling part and the terminals of the first interface form (at least a part of) the first connector of the monitoring device.

The monitoring device comprises a power supply unit for supplying power to the monitoring device. The power supply unit may include a battery. The power supply unit may comprise charging circuitry connected to the battery and to terminals of the first interface for charging the battery via the first interface, e.g. the first connector. The first interface may comprise separate charging terminal(s) for charging the battery. Additionally or alternatively, the sensor terminals may change their function if a charging voltage is sensed at the relevant terminal.

The monitoring device may comprise a sensor unit having one or more sensors. The sensor unit is connected to the processor for feeding sensor data to the processor. The sensor unit may comprise an accelerometer for sensing acceleration and providing acceleration data to the processor. The sensor unit may comprise a temperature sensor for providing temperature data to the processor.

The monitoring device includes a second interface connected to the processor. The second interface may be configured as an accessory interface for connecting the monitoring device to one or more accessory devices, e.g. wirelessly. The second interface may include, for example, an antenna and a wireless transceiver configured for wireless communication at frequencies in the range from 2.4 to 2.5 GHz. The wireless transceiver may be a bluetooth transceiver, i.e., the wireless transceiver may be configured for wireless communication according to a bluetooth protocol (e.g., bluetooth low energy technology, bluetooth 4.0, bluetooth 5). The second interface optionally comprises a speaker and/or a haptic feedback element for providing audio signals and/or haptic feedback, respectively, to the user.

The monitoring device may be electrically coupled to the base plate and/or the plurality of electrodes of the sensor assembly portion. For example, the monitoring device may be coupleable, such as releasably coupled, to the plurality of electrodes of the base plate and/or the sensor assembly portion. The monitoring device may be configured to measure one or more resistances between the plurality of electrodes and detect a leak of the effluent based on the measured one or more resistances.

In one or more exemplary ostomy systems, the monitoring device forms an integral part of the ostomy appliance, e.g. the monitoring device may form an integral part of the base plate and/or the sensor assembly part of the ostomy appliance.

The ostomy system may comprise a docking station forming an alternative/additional accessory to the ostomy system. The docking station may be configured to electrically and/or mechanically couple the monitoring device to the docking station.

The docking station may include a monitor expansion interface. The monitor expansion interface may be configured to electrically and/or mechanically connect the monitoring device to the docking station. The monitor expansion interface may be configured to wirelessly connect the monitoring device to the docking station. The monitor docking interface of the docking station may be configured to electrically and/or mechanically couple the docking station and the monitoring device.

The monitor expansion interface of the docking station may comprise a coupling for forming a mechanical connection, such as a releasable coupling, between the monitoring device and the docking station, e.g. as part of the first connector of the monitor expansion interface. The coupling portion may be configured to engage with a coupling portion of a monitoring device to releasably couple the monitoring device to the docking station.

The monitor expansion interface of the docking station may include a plurality of terminals, such as two, three, four, five, six, seven, or more terminals, for example, as part of the first connector of the monitor expansion interface for forming electrical connections with corresponding terminals of the monitoring device. The monitor extension interface may include a ground terminal. The monitor expansion interface may include a first terminal and/or a second terminal. The docking station may include a third terminal. The monitor extension interface may include a fourth terminal and/or a fifth terminal. The monitor extension interface optionally includes a sixth terminal.

Fig. 1 illustrates an exemplary ostomy system. Theostomy system 1 comprises anostomy appliance 2 having abase plate 4. Thebase plate 4 is adapted for supporting an ostomy bag (not shown). In addition, theostomy system 1 comprises amonitoring device 6 and an accessory device 8 (mobile phone). Themonitoring device 6 may be connected to thebackplane 4 via respective first connectors of themonitoring device 6 and thebackplane 4. Themonitoring device 6 is configured for wireless communication with theaccessory device 8. Optionally, theaccessory device 8 is configured for communication with aserver device 10 of theostomy system 1, e.g. via anetwork 12. Theserver device 10 may be operated and/or controlled by an ostomy appliance manufacturer and/or a service center. Ostomy data or parameter data based on ostomy data is obtained from electrodes/sensors of anostomy appliance 2 with amonitoring device 6. Themonitoring device 6 processes ostomy data and/or parameter data based on ostomy data. Based on the processed ostomy data, themonitoring device 6 may determine what monitor data is sent to theaccessory device 8. In the illustrated ostomy system, theaccessory device 8 is a mobile phone, but theaccessory device 8 may be implemented as another hand-held device, such as a tablet device, or a wearable device, such as a watch or other wrist-worn electronic device. Thus, themonitoring device 6 is configured to determine and send monitor data to theaccessory device 8. Thebase plate 4 comprises a coupling member 14 in the form of a coupling ring 16 for coupling an ostomy bag (not shown) to the base plate (two-piece ostomy appliance). Thebase plate 4 has a stoma opening 18 with acentre point 19. The size and/or shape of the stoma opening 18 is typically adjusted by the user or nurse to accommodate the stoma of the user prior to application of the ostomy appliance.

Theostomy system 1 optionally comprises adocking station 20 forming an alternative/additional accessory to theostomy system 1. Thedocking station 20 comprises a monitor docking interface comprising afirst connector 22 configured for electrically and/or mechanically connecting themonitoring device 6 to thedocking station 20. The monitor expansion interface may be configured to wirelessly connect the monitoring device to the docking station. Thedocking station 20 includes auser interface 24 for receiving user input and/or providing feedback to the user regarding the operational status of thedocking station 20. Theuser interface 24 may comprise a touch screen. Theuser interface 24 may include one or more physical buttons, and/or one or more visual indicators, such as light emitting diodes.

Fig. 2 is a schematic block diagram of an exemplary monitoring device. Themonitoring device 6 includes amonitoring device housing 100, aprocessor 101, and one or more interfaces including a first interface 102 (appliance interface) and a second interface 104 (accessory interface). Themonitoring device 6 comprises amemory 106 for storing ostomy data and/or parameter data based on ostomy data. Thememory 106 is connected to theprocessor 101 and/or thefirst interface 102.

Thefirst interface 102 is configured to electrically and/or mechanically connect themonitoring device 6 to an appliance interface of an ostomy appliance, such as theostomy appliance 2. Thefirst interface 102 comprises a plurality of terminals to form an electrical connection with corresponding terminals of the ostomy appliance 2 (base plate 4). Thefirst interface 102 includes aground terminal 108, afirst terminal 110, asecond terminal 112, and athird terminal 114. Thefirst interface 102 optionally includes afourth terminal 116 and afifth terminal 118. Thefirst interface 102 of themonitoring device 6 comprises acoupling 120 for forming a mechanical connection, such as a releasable coupling, between the monitoring device and the backplane. Thecoupling portion 120 and theterminals 108, 110, 112, 114, 116, and 118 of thefirst interface 102 form (at least a part of) a first connector of themonitoring device 6.

Themonitoring device 6 comprises apower supply unit 121 for powering the monitoring device and its active components, i.e. thepower supply unit 121 is connected to theprocessor 101, thefirst interface 102, thesecond interface 104, and thememory 106. The power supply unit includes a battery and charging circuitry. Charging circuitry is connected to the battery and to terminals of thefirst interface 102 to charge the battery via terminals of the first interface, e.g. terminals of the first connector.

Thesecond interface 104 of the monitoring device is configured as an accessory interface for connecting themonitoring device 6 to one or more accessory devices, such asaccessory device 8. Thesecond interface 104 includes anantenna 122 and awireless transceiver 124 configured for wireless communication with the accessory device(s). Optionally, thesecond interface 104 comprises aspeaker 126 and/or ahaptic feedback element 128 for providing a corresponding audio signal and/or haptic feedback to the user.

Themonitoring device 6 optionally comprises asensor unit 140 connected to theprocessor 101. For example, thesensor unit 140 may comprise a temperature sensor for feeding temperature data to the processor, and/or a G-sensor or accelerometer for feeding acceleration data to theprocessor 101. Additionally or alternatively, thesensor unit 140 comprises a humidity sensor and/or an acoustic sensor. Thesensor unit 140 may comprise alternative and/or additional sensors suitable for and/or in connection with ostomy systems as described.

Theprocessor 101 is configured for applying a treatment scheme and thefirst interface 102 is configured for collecting ostomy data from a base plate and/or sensor assembly part coupled to the first interface, the ostomy data comprising leakage ostomy data from a leakage electrode of an ostomy appliance. The ostomy data optionally includes: first ostomy data from a first electrode pair of the base plate and/or the sensor assembly portion, second ostomy data from a second electrode pair of the base plate and/or the sensor assembly portion, and/or third ostomy data from a third electrode pair of the base plate and/or the sensor assembly portion. The ostomy data may be stored in thememory 106 and/or processed in theprocessor 101 to obtain parameter data. The parameter data may be stored in thememory 106. Theprocessor 101 is configured for applying a processing scheme, wherein applying the processing scheme comprises obtaining primary leakage parameter data based on primary leakage ostomy data; obtaining secondary leak parameter data based on the secondary leak ostomy data; and obtaining tertiary leak parameter data based on the tertiary leak ostomy data. Optionally, the processing scheme comprises: obtaining first parameter data based on the first ostomy data; obtaining second parameter data based on the second ostomy data; third parameter data is obtained based on the third ostomy data. In other words, theprocessor 101 may be configured for obtaining the first, second and third parameter data based on the respective first, second and third ostomy data. The application processing scheme comprises: determining an operational state of a base plate and/or a sensor assembly part of an ostomy appliance based on one or more, e.g. all, of the primary, secondary and tertiary leakage parameter data, wherein the operational state is indicative of a severe leakage risk in a sensing region of the ostomy appliance. Themonitoring device 6 is configured for: in accordance with a determination that the operating state is a primary leak operating state, transmitting a primary leak monitor signal via the second interface, the primary leak monitor signal including monitor data indicative of the primary leak operating state of the backplane and/or the sensor assembly portion; and in accordance with a determination that the operating state is a secondary leak operating state, sending a secondary leak monitor signal via the second interface, the secondary leak monitor signal including monitor data indicative of the secondary leak operating state of the baseplate and/or the sensor assembly portion. Themonitoring device 6 may be configured to transmit a tertiary leak monitor signal including monitor data indicative of a tertiary leak operating state of the backplane and/or the sensor assembly portion via the second interface in accordance with the determination that the operating state is a tertiary leak operating state.

Fig. 3 shows an exploded view of an exemplary base plate of an ostomy appliance. Thebase plate 4 comprises a firstadhesive layer 200 having astoma opening 18A. During use, the proximal surface of the firstadhesive layer 200 adheres into the stoma perimeter area of the user's skin and/or to additional sealing elements, such as sealing pastes, sealing tapes and/or sealing rings. Thebase plate 4 optionally comprises a secondadhesive layer 202, also referred to as rim adhesive layer, having astoma opening 18B. Thebottom plate 4 includes a plurality of electrodes arranged in theelectrode assembly 204. Theelectrode assembly 204 is disposed between the firstadhesive layer 200 and the secondadhesive layer 202. Theelectrode assembly 204 includes a support layer having astoma opening 18C and an electrode formed on a proximal surface of the support layer. Thebase plate 4 comprises arelease liner 206 which is peeled off by the user before applying thebase plate 4 to the skin. Thebase plate 4 comprises atop layer 208 having astoma opening 18D and acoupling ring 209 for coupling the ostomy bag to thebase plate 4. Thetop layer 208 is a protective layer that protects the secondadhesive layer 202 from external strains and stresses during use.

Thebackplane 4 includes a monitor interface. The monitor interface is configured for electrically and/or mechanically connecting the ostomy appliance (base plate 4) to a monitoring device. The monitor interface of the base plate comprises acoupling portion 210 for forming a mechanical connection, such as a releasable coupling, between the monitoring device and the base plate. Thecoupling portion 210 is configured to engage with a coupling portion of a monitoring device to releasably couple the monitoring device to thebase plate 4. In addition, the monitor interface of thebackplane 4 comprises a plurality of terminal elements which respectively form a plurality of terminals 212 for making electrical connection with corresponding terminals of the monitoring device. Thecoupling portion 210 and the terminal 212 form afirst connector 211 of thebase plate 4. Thebase plate 4 comprises a first intermediate element 213 on the proximal side of the electrode assembly. The first intermediate member 213 is disposed between the terminal member forming the terminal 212 and a first adhesive layer (not shown). The first intermediate member 213 covers the terminal members forming the terminals 212 of thebase plate 4 when viewed in the axial direction, and protects the first adhesive layer from mechanical stress from the terminal members of the base plate.

As previously described, portions of the illustratedbackplane 4 may be provided as separate components to be applied to an existing backplane, for example including one or more of the components as described, for example to provide a backplane similar to thebackplane 4 described. For example, asensor assembly portion 700 may be provided, for example, including anelectrode assembly 204, afirst connector 211, a first intermediate element 213, a firstadhesive layer 200, and arelease liner 206. Additionally, thesensor assembly portion 700 may also include a secondadhesive layer 202 and/or atop layer 208. It is contemplated that a user may provide a hole in the layer of the base plate to which thesensor assembly portion 700 is to be applied to allow thefirst connector 211 of thesensor assembly portion 700 to protrude through the layer of the base plate to which thesensor assembly portion 700 is to be applied. Alternatively, thesensor assembly portion 700 may be applied to the base plate such that thefirst connector 211 is positioned outside the outer perimeter of the base plate.

Fig. 4 illustrates an exploded view of anexemplary electrode assembly 204 of the base plate and/or sensor assembly portion. Theelectrode assembly 204 has adistal side 204A and a proximal side 204B. Theelectrode assembly 204 includes asupport layer 214 having aproximal surface 214B, and a plurality ofelectrodes 216 disposed on a proximal side of thesupport layer 214 and including a ground electrode, a first electrode, a second electrode, a third electrode, a fourth electrode, and a fifth electrode, wherein each electrode has arespective connection 217 for connecting theelectrode 216 to a respective terminal element of the monitor interface. Theelectrodes 216 are positioned and/or formed on theproximal side 214B of thesupport layer 214. In addition, theelectrode assembly 204 includes amasking element 218 having aproximal surface 218B and configured to insulate an electrode portion of theelectrode 216 from the base plate and/or the first adhesive layer of the sensor assembly portion. The maskingelement 218 covers or overlaps a portion of theelectrode 216 when viewed in the axial direction.

Fig. 5 is a proximal side view of the proximal surface of the base plate and/or the base plate portion of the sensor assembly portion without the first adhesive layer and release liner. Thebase plate 4 and/or thesensor assembly portion 700 comprise a first intermediate element 213 on the proximal side of the electrode assembly, i.e. between theelectrode assembly 204 and a first adhesive layer (not shown). The first intermediate element 213 covers the terminal elements of thebase plate 4, as seen in the axial direction, and protects the first adhesive layer from mechanical stress from the base plate and/or the terminal elements of the sensor assembly portion.

Fig. 6 is a distal view of anexemplary electrode configuration 220 of theelectrodes 216 of theelectrode assembly 204.Electrode assembly 204, such aselectrode configuration 220 ofelectrode assembly 204, includes aground electrode 222, a first electrode 224, a second electrode 226, a third electrode 228, afourth electrode 230, and afifth electrode 232. Theground electrode 222 includes aground connection 222A, and the first electrode 224 includes afirst connection 224A. The second electrode 226 includes asecond connection portion 226A, and the third electrode 228 includes athird connection portion 228A. Thefourth electrode 230 includes afourth connection portion 230A, and thefifth electrode 232 includes afifth connection portion 232A.

The fourth electrode (second leakage electrode) 230 includes afourth sensing portion 230B. The fifth electrode (third leakage electrode) 232 includes afifth sensing part 232B.

Theground electrode 222 includes afirst electrode portion 234 for forming a ground or reference for the first electrode 224. Theground electrode 222 includes asecond electrode portion 236 for forming a ground or reference for the second electrode 226. Theground electrode 222 includes athird electrode portion 238 for forming a ground or reference for the third electrode 228. Maskingelement 218 is disposed proximal toelectrodes 222, 224, 226, 228, covering and insulating a portion of these electrodes from the first adhesive and forming respective conductor portions ofelectrodes 222, 224, 226, 228. These portions ofelectrodes 222, 224, 226, 228 not covered by maskingelement 219 contact the first adhesive layer and form sensing portions 224B, 226B, 228B of electrodes 224, 226, 228, respectively. In addition, theelectrode portions 234, 236, 238 form sensing portions of theground electrode 222.

The first sensing portion 224B extends circularly at least 330 degrees around the stoma opening at a first radial distance R1 from thecentre point 19, see also fig. 11. The first radial distance R1 is 14 mm. Thefirst electrode portion 234 is arranged on the inner side of the first sensing portion (i.e. closer to the centre point) and extends circularly around the stoma opening at least 330 degrees at a first grounding distance RG1 from the first sensing portion (radially from the centre point). The first ground distance RG1 is about 1 mm.

The second sensing portion 226B extends circularly around the stoma opening at a second radial distance R2 from thecentre point 19, at least 330 degrees, see also fig. 11. The second radial distance R2 is 18 mm. Thesecond electrode portion 236 is arranged on the inner side of the second sensing portion 226B (i.e. closer to the centre point) and extends circularly around the stoma opening at least 330 degrees at a second grounding distance RG2 from the second sensing portion 226B (radially from the centre point). The second ground distance RG2 is about 1 mm.

The third sensing portion 228B extends circularly at least 330 degrees around the stoma opening at a third radial distance R3 from thecentre point 19, see also fig. 11. The third radial distance R3 is about 26 mm. Thethird electrode portion 238 is arranged on the inner side of the third sensing portion 228B (i.e. closer to the centre point) and extends circularly around the stoma opening at least 330 degrees at a third grounding distance RG3 from the third sensing portion 228B (radially from the centre point). The third ground distance RG3 is about 1 mm.

Theground electrode 222 includes afourth electrode portion 240 for forming a ground or reference for thefourth electrode 230 and thefifth electrode 232. Thefourth electrode portion 240 of the ground electrode forms a first leakage electrode. Thefourth electrode portion 240 of theground electrode 222 extends at least 300 degrees around the stoma opening and includes aground sensing portion 222B. Thefourth sensing part 230B, thefifth sensing part 232B, and the grounded sensing part of thefourth electrode part 240 are circularly distributed around thecenter point 19 at a leakage radius from the center point. Thefourth sensing section 230B, thefifth sensing section 232B, and the grounded sensing section of the fourth electrode section may have a radial extension larger than 1.0mm, such as in the range from 1.5mm to 3.0mm, for example about 2.0 mm. Thefourth sensing section 230B, thefifth sensing section 232B, and the grounded sensing section of thefourth electrode section 240 may have a circumferential extension (perpendicular to the radial extension) of more than 1.0mm, such as in the range from 2.5mm to 5.0mm, for example about 3.5 mm. In one or more exemplary base plates and/or sensor assembly portions, electrodes 224, 226, 228 andelectrode portions 234, 236, 238 may be omitted from the electrode configuration/assembly.

Fig. 7 is a distal view of an exemplary masking element. The maskingelement 218 optionally has a plurality of terminal openings (including six terminal openings). The plurality of terminal openings includes aground terminal opening 242, a firstterminal opening 244, a second terminal opening 246, a thirdterminal opening 248, a fourthterminal opening 250, and a fifthterminal opening 252. Theterminal openings 242, 244, 246, 248, 250, 252 of themasking element 218 are configured to overlap and/or align with therespective connections 222A, 224A, 226A, 228A, 230A, 232A of the electrodes of the electrode assembly.

The maskingelement 218 has a plurality of sensor spot openings. These sensor spot openings include primary sensor spot openings, shown within dashedline 254, each configured to overlap a portion of ground electrode (first leaky electrode) 222, and/or a portion of fourth electrode (second leaky electrode) 230. In the illustrated example masking element, the primarysensor spot openings 254 include five primarysensor spot openings 254A, each configured to overlap a respective sensing portion of the ground electrode (first leakage electrode) 222. In the illustrated example masking element, the primarysensor spot openings 254 include four primarysensor spot openings 254B, each configured to overlap a respective sensing portion of the fourth electrode (second leakage electrode) 230. These sensor spot openings include secondary sensor spot openings, shown within dashedline 256, each configured to overlap a portion of the fourth electrode (second leakage electrode) 230, and/or a portion of the fifth electrode (third leakage electrode) 232. In the illustrated exemplary masking element, the secondarysensor spot openings 256 include five secondarysensor spot openings 256A, each configured to overlap a respective sensing portion of the fifth electrode (third leakage electrode) 232. In the illustrated exemplary masking element, the secondarysensor dot openings 256 include four secondarysensor dot openings 256B, each configured to overlap a respective sensing portion of the fourth electrode (second leakage electrode) 230. These sensor spot openings include tertiary sensor spot openings, shown within dashedline 258, each configured to overlap a portion of fifth electrode (third leakage electrode) 232, and/or a portion of ground electrode (first leakage electrode) 222. In the illustrated example masking element, the tertiarysensor spot openings 258 include five tertiarysensor spot openings 258A, each configured to overlap a respective sensing portion of the fifth electrode (third leakage electrode) 232. In the illustrated example masking element, the tertiarysensor point openings 258 include four tertiarysensor point openings 258B, each configured to overlap a respective sensing portion of the ground electrode (first leakage electrode) 222. Thesensor spot openings 254A, 254B, 256A, 256B, 258A, 258B are circularly arranged at a leakage radius of about 30mm from thecenter point 19.

Fig. 8 is a distal view of an exemplary first adhesive layer. The firstadhesive layer 200 has a plurality of sensor dot openings. The sensor dot openings of the first adhesive layer include primary sensor dot openings, shown within dashedline 260, each configured to overlap a portion of theground electrode 222, and/or a portion of thefourth electrode 230, of the electrode assembly. In the illustrated exemplary first adhesive layer, the primary sensor dot openings include five primarysensor dot openings 260A, each configured to overlap a respective sensing portion of theground electrode 222. In the illustrated exemplary first adhesive layer, the primary sensor dot openings include four primarysensor dot openings 260B, each configured to overlap a respective sensing portion of thefourth electrode 230. The sensor dot openings of the first adhesive layer include secondary sensor dot openings shown within dashedlines 262, each second sensor dot opening being configured to overlap a portion of thefourth electrode 230, and/or a portion of thefifth electrode 232 of the electrode assembly. In the illustrated exemplary first adhesive layer, the secondary sensor dot openings include five secondarysensor dot openings 262A, each configured to overlap with a respective sensing portion of thefifth electrode 232. In the illustrated exemplary first adhesive layer, the secondary sensor dot openings include four secondarysensor dot openings 262B, each configured to overlap a respective sensing portion of thefourth electrode 230. The sensor dot openings of the first adhesive layer include tertiary sensor dot openings, shown within dashedline 264, each configured to overlap a portion of thefifth electrode 232, and/or a portion of theground electrode 222 of the electrode assembly. In the illustrated exemplary first adhesive layer, the three-level sensor dot openings include five three-levelsensor dot openings 264A, each configured to overlap a respective sensing portion of thefifth electrode 232. In the illustrated exemplary first adhesive layer, the three-level sensor dot openings include four three-levelsensor dot openings 264B, each configured to overlap a respective sensing portion ofground electrode 222.

Fig. 9 is a proximal side view of the first adhesive layer of fig. 8. Thesensor spot openings 260A, 260B, 262A, 262B, 264A, 264B are circularly arranged at a leak radius of about 30mm from a center point.

Fig. 10 is a more detailed distal view of a portion of thebase plate 4 and/or thesensor assembly portion 700. Thebackplane 4 and/or thesensor assembly portion 700 include a monitor interface. The monitor interface includes afirst connector 211. Thefirst connector 211 comprises acoupling portion 210 configured for releasably coupling the monitoring device to the floor and/or the sensor assembly portion and thereby forming a releasable coupling. Thefirst connector 211 of the monitor interface comprises a plurality of terminals formed by respective terminal elements for forming respective electrical connections with respective terminals of the monitoring device.

The plurality of terminals of thefirst connector 211 of the monitor interface includes a ground terminal element 282 forming a ground terminal 282A, a first terminal element 284 forming a first terminal 284, a second terminal element 286 forming a second terminal 286A, and optionally a third terminal element 288 forming a third terminal 288A. The monitor interface optionally includes a fourth terminal element 290 forming a fourth terminal 290A, and/or a fifth terminal element 292 forming a fifth terminal 292A. The terminal elements 282, 284, 286, 288, 290, 292 contact therespective connection portions 222A, 224A, 226A, 228A, 230a, 232A of theelectrodes 222, 224, 226, 228, 230, 232.

The position of the first connector on the base plate and/or the sensor assembly portion, the number of terminals, and the position of the terminals in the coupling portion may be adapted to the electrode configuration used in the electrode assembly of the base plate and/or the sensor assembly portion. For example, the first connector for the bottom plate and/or the sensor component part having theelectrode configuration 220A shown in fig. 11 includes four terminals connected to theconnection parts 222A, 224A, 226A, 228A of these electrodes, respectively, and the first connector for the bottom plate and/or the sensor component part plate having theelectrode configuration 220B shown in fig. 12 includes three terminals connected to theconnection parts 222A, 224A, 226A of these electrodes, respectively.

Fig. 11 is a distal view of theexemplary electrode configuration 220 of the base plate and/or sensor assembly portion of fig. 6.Electrode configuration 220 includes afirst leakage electrode 222, asecond leakage electrode 230, and athird leakage electrode 232.Leakage electrodes 222, 230, 232 are configured to detect the presence of fluid on the proximal side of the first adhesive layer in three sensing zones (three angular sensing zones in the illustrated example), namelyprimary sensing zone 400,secondary sensing zone 402, andtertiary sensing zone 404.Primary sensing region 400 is disposed in a primary angular space betweenfirst direction 406 andsecond direction 408 fromcenter point 19, where the primary angular space spans a primary angle V1 of 120 °.Secondary sensing zone 402 is disposed in a secondary angular space betweensecond direction 408 andthird direction 410 fromcenter point 19, wherein the secondary angular space spans a secondary angle V2 of 120 °.Tertiary sensing zone 404 is disposed in a tertiary angular space betweenthird direction 410 fromcenter point 19 andfirst direction 406, wherein the tertiary angular space spans a tertiary angle V3 of 120 °.

First leakage electrode 222 includes fiveprimary sensing parts 222D arranged inprimary sensing region 400, and fourtertiary sensing parts 222E arranged intertiary sensing region 404. Eachprimary sensing portion 222D is aligned with a respective primarysensor point opening 254A (see fig. 7) of themasking element 218. Further, eachprimary sensing portion 222D is aligned with a corresponding primarysensor dot opening 260A (see fig. 8) of the firstadhesive layer 200. Eachtertiary sensing portion 222E of thefirst leakage electrode 222 is aligned with a respective tertiarysensor point opening 258B (see fig. 7) of themasking element 218. Further, each tertiaryfirst sensing portion 222E is aligned with a respective tertiarysensor dot opening 264B (see fig. 8) of the firstadhesive layer 200.

Thesecond leakage electrode 230 includes fourprimary sensing parts 230D arranged in theprimary sensing region 400, and foursecondary sensing parts 230E arranged in thesecondary sensing region 402. Eachprimary sensing portion 230D is aligned with a respective primarysensor point opening 254B (see fig. 7) of themasking element 218. Further, eachprimary sensing portion 230D is aligned with a corresponding primarysensor dot opening 260B (see fig. 8) of the firstadhesive layer 200. Eachsecondary sensing portion 230E is aligned with a respective secondarysensor point opening 256B (see fig. 7) of themasking element 218. Further, eachsecondary sensing portion 230E is aligned with a corresponding secondarysensor dot opening 262B (see fig. 8) of the firstadhesive layer 200.

Third leakage electrode 232 includes fivesecondary sensing portions 232D arranged insecondary sensing region 402, and fivetertiary sensing portions 232E arranged intertiary sensing region 404. Eachsecondary sensing portion 232D is aligned with a respective secondarysensor spot opening 256A (see fig. 7) of themasking element 218. Further, eachsecondary sensing portion 232D is aligned with a corresponding secondarysensor dot opening 262A (see fig. 8) of the firstadhesive layer 200. Eachtertiary sensing portion 232E is aligned with a respective tertiarysensor point opening 258A (see fig. 7) of themasking element 218. Further, eachtertiary sensing portion 232E is aligned with a respective tertiarysensor spot opening 264A (see fig. 8) of the firstadhesive layer 200.

Thesensing portions 222D, 222E, 230D, 230E, 232D, 232E are circularly arranged at a leakage radius R L of about 30mm from a center point.

Fig. 12 is a distal view of anexemplary electrode configuration 220A of a base plate and/or sensor assembly portion.Electrode configuration 220 includes afirst leakage electrode 222, asecond leakage electrode 230, and athird leakage electrode 232.Leakage electrodes 222, 230, 232 are configured to detect the presence of fluid in two angular sensing zones,primary sensing zone 400 andsecondary sensing zone 402, on the proximal side of the first adhesive layer.Primary sense area 400 is disposed in a primary angular space betweenfirst direction 406 andsecond direction 408 fromcenter point 19, wherein the primary angular space spans a primary angle V1 of about 185 °.Secondary sense area 402 is disposed in a secondary angular space betweensecond direction 408 andfirst direction 406 fromcenter point 19, wherein the secondary angular space spans a secondary angle V2 of about 175 °.

First leakage electrode 222 includes aprimary sensing portion 222D disposed inprimary sensing zone 400, and asecondary sensing portion 222F disposed insecondary sensing zone 402,second leakage electrode 230 includes aprimary sensing portion 230D disposed inprimary sensing zone 400,third leakage electrode 232 includes asecondary sensing portion 232D disposed insecondary sensing zone 402, eachprimary sensing portion 222D, 230D is aligned with a respective primary sensor point opening of masking element 219 (see fig. 13) and a respective primary sensor point opening of first adhesive layer 201 (see fig. 14),sensing portions 222D, 222F, 230D, and 232D are circularly disposed at a leakage radius R L of about 30mm from a center point.

Fig. 13 is a distal view of amasking layer 219 for theelectrode configuration 220A of fig. 12. Themasking layer 219 includes primarysensor dot openings 254 and secondarysensor dot openings 256. Fig. 14 is a distal view of the firstadhesive layer 201 for theelectrode configuration 220A of fig. 12, implementing a backplane and/or sensor assembly portion having two sensing zones arranged in separate angular spaces. Themasking layer 201 includes primarysensor dot openings 260 and secondarysensor dot openings 262.

Fig. 15 is a distal view of anexemplary electrode configuration 220B of a base plate and/or sensor assembly portion.Electrode configuration 220B includesfirst leakage electrode 222,second leakage electrode 230,third leakage electrode 232,fourth leakage electrode 412, andfifth leakage electrode 414.Leakage electrodes 222, 230, 232, 412, 414 are configured to detect the presence of fluid in fourangular sensing zones 400, 402, 404, 416 on a proximal side of the first adhesive layer.Primary sense area 400 is disposed in a primary angular space spanning a primary angle V1 of about 85 °.Secondary sense region 402 is disposed in a secondary angular space spanning a secondary angle V2 of about 95 °.Tertiary sensing zone 404 is disposed in a tertiary angular space spanning a tertiary angle V3 of about 95 °.Quaternary sense zone 416 is disposed in a quaternary angular space spanning a quaternary angle V4 of about 85 °.

Although exemplary base plates and/or sensor assembly portions having two, three, and four sensing zones have been described in greater detail, the base plate and/or sensor assembly portion may include one or a greater number of sensing zones, such as five, six, seven, eight, or more sensing zones.

Fig. 16 is a flow diagram of an exemplary method for monitoring a base plate and/or sensor assembly portion of an ostomy appliance, the base plate and/or sensor assembly portion including a first adhesive layer having a proximal side configured for attaching the base plate and/or sensor assembly portion to a skin surface of a user and a stoma opening with a center point, and a plurality of electrodes including a first leakage electrode, a second leakage electrode, and a third leakage electrode. Themethod 1000 includes: obtaining 1002 a primary sensor signal (primary leak ostomy data) from the first leak electrode and the second leak electrode; detecting 1004 the presence of fluid in a primary sensing zone on the proximal side based on the primary sensor signal (primary leak ostomy data); obtaining 1006 a secondary sensor signal (secondary leak ostomy data) from the second leak electrode and the third leak electrode; detecting 1008 a presence of fluid in a secondary sensing region on the proximal side based on the secondary sensor signal (secondary leak ostomy data); and providing 1012 a leak indicator, e.g., a wireless monitor signal from a monitoring device to an accessory device, in accordance with 1010 detecting the presence of fluid in the primary sensing zone and/or the secondary sensing zone to indicate that a sensing zone in which the presence of liquid has been detected. If no fluid is detected, the method returns to obtaining 1002 a primary sensor signal (primary leak ostomy data) from the first leaking electrode and the second leaking electrode.

Themethod 1000 includes: obtaining 1002 a primary sensor signal (primary leak ostomy data) from the first leak electrode and the second leak electrode; detecting 1004 the presence of fluid in a primary sensing zone on the proximal side based on the primary sensor signal (primary leak ostomy data); obtaining 1006 a secondary sensor signal (secondary leak ostomy data) from the second leak electrode and the third leak electrode; detecting 1008 a presence of fluid in a secondary sensing region on the proximal side based on the secondary sensor signal (secondary leak ostomy data); and providing 1012 a leak indicator, e.g., a wireless monitor signal from a monitoring device to an accessory device, in accordance with 1010 detecting the presence of fluid in the primary sensing zone and/or the secondary sensing zone to indicate that a sensing zone in which the presence of liquid has been detected. If no fluid is detected, the method returns to obtaining 1002 a primary sensor signal (primary leak ostomy data) from the first leaking electrode and the second leaking electrode.

The use of the terms "first," "second," "third," and "fourth," "primary/secondary," "secondary/tertiary," etc. do not imply any particular order, but are included to identify individual elements. Moreover, the use of the terms "first," "second," "third," and "fourth," "primary/secondary," "tertiary," etc. do not denote any order or importance, but rather the terms "first," "second," "third," and "fourth," "primary/secondary," "secondary/tertiary," etc. are used to distinguish one element from another. It should be noted that the terms "first," "second," "third," and "fourth," "primary/secondary," "tertiary," and the like are used herein and elsewhere for purposes of notation and are not intended to imply any particular spatial or temporal order. In addition, the labeling of a first element does not imply the presence of a second element and vice versa.

While particular features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and that various changes and modifications may be apparent to those skilled in the art without departing from the spirit and scope of the claimed invention. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense. The claimed invention is intended to cover all alternatives, modifications, and equivalents.

Embodiments of the disclosure are set forth in the following clauses:

1. a sensor assembly portion for an ostomy appliance, the sensor assembly portion comprising:

-a first adhesive layer having a proximal side configured for attaching the sensor assembly portion onto a skin surface of a user, the first adhesive layer having a stoma opening with a centre point; and

a plurality of electrodes including a first leaky electrode, a second leaky electrode, and a third leaky electrode,

wherein the plurality of electrodes are configured to detect the presence of fluid on a proximal side of the first adhesive layer in a primary sensing zone and a secondary sensing zone, the primary sensing zone being disposed in a primary angular space from a center point of the first adhesive layer and the secondary sensing zone being disposed in a secondary angular space from a center point of the first adhesive layer.

2. The sensor assembly portion ofclause 1, wherein the primary angular space spans a primary angle in a range from 45 ° to 315 °.

3. The sensor assembly portion according to any one ofclauses 1 to 2, wherein the secondary angular space spans a secondary angle in a range from 45 ° to 315 °.

4. The sensor assembly portion of any of clauses 1-3, wherein the primary sensing zone and the secondary sensing zone are separate sensing zones.

5. The sensor assembly portion of any of clauses 1-4, wherein the first leakage electrode comprises one or more primary first sensing portions disposed in the primary sensing zone.

6. The sensor assembly portion of any of clauses 1-5, wherein the second leakage electrode comprises one or more primary second sensing portions disposed in the primary sensing zone.

7. The sensor assembly portion of any of clauses 1-6, wherein the second leakage electrode comprises one or more secondary second sensing portions disposed in the secondary sensing zone.

8. The sensor assembly portion of any of clauses 1-7, wherein the third leakage electrode comprises one or more secondary third sensing portions disposed in the secondary sensing zone.

9. The sensor assembly portion of any of clauses 1-8, wherein the plurality of electrodes are configured to detect the presence of fluid on the proximal side in a tertiary sensing zone disposed in a tertiary angular space from a center point of the first adhesive layer.

10. The sensor assembly portion according to clause 9, wherein the three-level angular space spans three-level angles in a range from 45 ° to 180 °.

11. The sensor assembly portion of any of clauses 9-10, wherein the primary and tertiary sensing zones are separate sensing zones.

12. The sensor assembly portion of any of clauses 9-11, wherein the first leakage electrode comprises one or more tertiary first sensing portions arranged in the tertiary sensing zone.

13. The sensor assembly portion of any of clauses 9-12, wherein the third leakage electrode comprises one or more tertiary third sensing portions arranged in the tertiary sensing zone.

14. A method for monitoring a sensor assembly portion of an ostomy appliance, the sensor assembly portion comprising a first adhesive layer having a proximal side configured for attaching the sensor assembly portion to a skin surface of a user and a stoma opening with a center point, and a plurality of electrodes comprising a first leakage electrode, a second leakage electrode, and a third leakage electrode, the method comprising:

obtaining a primary sensor signal from the first leakage electrode and the second leakage electrode;

detecting a presence of fluid in a primary sensing zone on the proximal side based on the primary sensor signal;

obtaining a secondary sensor signal from the second leakage electrode and the third leakage electrode;

detecting a presence of fluid in a secondary sensing zone on the proximal side based on the secondary sensor signal; and

in response to detecting the presence of fluid in the primary and/or secondary sensing zones, providing a leak indicator to indicate that the sensing zone has been detected to be in the presence of liquid.

15. A monitoring device for an ostomy system comprising an ostomy appliance having a base plate with a first adhesive layer having a proximal side configured for attaching the base plate to a skin surface of a user, the first adhesive layer having a stoma opening with a center point, the monitoring device comprising:

a processor;

a memory;

a first interface connected to the processor and the memory, the first interface configured to obtain ostomy data from a base plate coupled to the first interface, the ostomy data comprising primary leakage ostomy data from a primary set of electrodes of the base plate and secondary leakage ostomy data from a secondary set of electrodes of the base plate; and

a second interface connected to the processor,

wherein the processor is configured to:

-obtaining primary leakage parameter data based on the primary leakage ostomy data;

-obtaining secondary leakage parameter data based on the secondary leakage ostomy data;

-detecting the presence of fluid on a proximal side of the first adhesive layer based on the primary leakage parameter data in a primary sensing zone arranged in a primary angular space from a center point of the first adhesive layer;

-detecting the presence of fluid on a proximal side of the first adhesive layer based on the secondary leakage parameter data in a secondary sensing zone arranged in a secondary angular space from a center point of the first adhesive layer;

-upon detecting the presence of fluid in the primary sensing zone, transmitting a primary leak monitor signal via the second interface, the primary leak monitor signal containing monitor data indicative of the presence of fluid in the primary sensing zone; and

-upon detecting the presence of fluid in the secondary sensing zone, transmitting a secondary leak monitor signal via the second interface, the secondary leak monitor signal containing monitor data indicative of the presence of fluid in the secondary sensing zone.

16. The monitoring device of clause 15, wherein the ostomy data comprises tertiary leakage ostomy data from a tertiary electrode set of the base plate, wherein the processor is configured for:

-obtaining tertiary leakage parameter data based on the primary leakage ostomy data;

-detecting the presence of fluid on a proximal side of the first adhesive layer based on the tertiary leakage parameter data in a tertiary sensing zone arranged in a tertiary angular space from a center point of the first adhesive layer; and

-upon detecting the presence of fluid in the tertiary sensing zone, transmitting a tertiary leak monitor signal via the second interface, the tertiary leak monitor signal containing monitor data indicative of the presence of fluid in the tertiary sensing zone.

17. The monitoring device of any of clauses 15-16, wherein detecting the presence of fluid in a primary sensing zone on a proximal side of the first adhesive layer based on the primary leak parameter data is based on a primary leak indicator set, wherein if the primary leak indicator set is satisfied, fluid is present in the primary sensing zone.

18. The monitoring device of clause 17, wherein the set of primary leakage indicators is based on a primary leakage threshold value stored in the memory.

19. The monitoring device of any of clauses 15-18, wherein detecting the presence of fluid in a secondary sensing zone on the proximal side of the first adhesive layer based on the secondary leak parameter data is based on a secondary leak indicator set, wherein if the secondary leak indicator set is satisfied, fluid is present in the secondary sensing zone.

20. The monitoring device ofclause 19, wherein the set of secondary leakage indicators is based on a secondary leakage threshold value stored in the memory.

21. The monitoring device of any of clauses 15-20, when dependent on clause 16, wherein detecting the presence of fluid in a tertiary sensing zone on the proximal side of the first adhesive layer based on the tertiary leakage parameter data is based on a tertiary leakage index set, wherein if the tertiary leakage index set is satisfied, fluid is present in the tertiary sensing zone.

22. The monitoring device of clause 21, wherein the set of tertiary leakage indicators is based on a tertiary leakage threshold value stored in the memory.

23. The monitoring device of any one of clauses 15 to 22, wherein the second interface comprises a speaker connected to the processor, and wherein the processor is configured to transmit a monitor signal via the speaker.

24. The monitoring device of any one of clauses 15 to 23, wherein the second interface comprises an antenna and a wireless transceiver, and wherein the processor is configured to transmit the monitor signal as a wireless monitor signal via the antenna and the wireless transceiver.

25. An ostomy system comprising an ostomy appliance comprising a base plate and a monitoring device, wherein the monitoring device is a monitoring device according to any of clauses 15-24.

List of reference numerals

1 ostomy system

2 ostomy appliance

4 bottom plate

6 monitoring device

8 attachment

10 server device

12 network

14 coupling member

16 coupling ring

18. 18A, 18B, 18C, 18D stoma opening

20 docking station

22 first connector

24 user interface

100 monitor device housing

101 processor

102 first interface

104 second interface

106 memory

108 ground terminal of monitoring device

110 first terminal of monitoring device

112 second terminal of the monitoring device

114 monitoring a third terminal of the device

116 fourth terminal of monitoring device

118 fifth terminal of monitoring device

120 coupling part

121 power supply unit

122 antenna

124 wireless transceiver

126 speaker

128 tactile feedback element

140 sensor unit

200. 201 first adhesive layer

200A distal surface of first adhesive layer

200B proximal surface of first adhesive layer

202 second adhesive layer

202A distal surface of the second adhesive layer

202B proximal surface of second adhesive layer

204 electrode assembly

204A distal surface of the electrode assembly

204B proximal surface of electrode assembly

206 Release liner

Distal surface of 206A release liner

206B proximal surface of release liner

208 top layer

208A distal surface of the top layer

208B proximal surface of the top layer

209 coupling ring

210 coupling part of first connector

211 first connector

212 terminal of the first connector

213 first intermediate element

213A distal surface of the first intermediate element

213B proximal surface of the first intermediate element

214 support layer of electrode assembly

214A support layer distal surface

214B support layer proximal surface

216 electrodes of electrode assembly

217 electrode connection part

218. 219 masking element

218A distal surface of masking element

218B proximal surface of masking element

220. 220A, 220B electrode configuration

222 ground electrode, first leakage electrode

222A ground connection

222B ground sensing part, sensing part of the first leakage electrode

222C ground connector section

222D first-level sensing part

222E three-level sensing part

222F two-stage sensing part

224 first electrode

224A first connection

224B first sensing part

224C first conductor portion

226 second electrode

226A second connecting part

226B second sensing part

226C second conductor part

228 third electrode

228A third connecting part

228B third sensing portion

228C third conductor part

230 fourth electrode, second leakage electrode

230A fourth connecting part

230B fourth sensing part, sensing part of second leakage electrode

230D first-level sensing part

230E two-stage sensing part

232 fifth electrode and third leakage electrode

232A fifth connecting part

232B fifth sensing part, sensing part of third leakage electrode

232D two-stage sensing part

232E three-level sensing part

234 first electrode portion of ground electrode

236 second electrode portion of the ground electrode

238 third electrode part of ground electrode

240 fourth electrode portion of the ground electrode

242 ground terminal opening

244 first terminal opening

246 second terminal opening

248 third terminal opening

250 fourth terminal opening

252 fifth terminal opening

254 primary sensor spot opening of masking element

Primary sensor spot opening of 254A ground electrode (first leakage electrode)

254B fourth electrode (second leakage electrode)

256 masking element Secondary sensor dot opening

256A fifth electrode (third leakage electrode) two-level sensor spot opening

256B second level sensor spot opening for fourth electrode (second leakage electrode)

258 tertiary sensor spot opening of masking element

258B fifth electrode (third leakage electrode) three-level sensor spot opening

258A ground electrode (first leakage electrode) three-level sensor point opening

260 first level sensor dot openings of a first adhesive layer

First-order sensor point opening of 260A ground electrode (first leakage electrode)

260B first order sensor spot opening of fourth electrode (second leakage electrode)

262 second level sensor dot opening of first adhesive layer

262A second level sensor spot opening for the fifth electrode (third leakage electrode)

262B second level sensor spot opening of fourth electrode (second leakage electrode)

264 tertiary sensor spot opening of a first adhesive layer

264A fifth electrode (third leakage electrode) three level sensor spot opening

Triple level sensor point opening for 264B ground electrode (first leaky electrode)

282 ground terminal element

282A ground terminal

284a first terminal element

284A first terminal

286 second terminal element

286A second terminal

288 third terminal element

288A third terminal

290 fourth terminal element

290A fourth terminal

292 fifth terminal element

292A fifth terminal

400 primary sensing region

402 secondary sensing region

404 three-level sensing region

406 first/zero direction

408 second direction

410 third direction

412 fourth leakage electrode

414 fifth drain electrode

416 four-level sensing region

418 fourth direction

700 sensor assembly part

1000 method for monitoring a base plate and/or a sensor assembly part of an ostomy appliance

1002 obtaining a primary sensor signal

1004 detecting the presence of fluid in a primary sensing zone

1006 obtaining a secondary sensor signal

1008 detecting the presence of fluid in a secondary sensing zone

1010 detecting the presence of fluid

1012 provide a leak indicator

R1 first radial distance

RG1 first ground distance

R2 second radial distance

Second ground distance of RG2

R3 third radial distance

Third ground distance of RG3

R L leak radius

Primary angle of V1

V2 two-stage angle

Angle of three levels of V3

Angle of three levels of V4

Claims (14)

1. A base plate for an ostomy appliance, the base plate comprising:

-a first adhesive layer having a proximal side configured for attaching the base plate to a skin surface of a user, the first adhesive layer having a stoma opening with a central point; and

a plurality of electrodes including a first leaky electrode, a second leaky electrode, and a third leaky electrode,

wherein the plurality of electrodes are configured to detect the presence of fluid on a proximal side of the first adhesive layer in a primary sensing zone and a secondary sensing zone, the primary sensing zone being disposed in a primary angular space from a center point of the first adhesive layer and the secondary sensing zone being disposed in a secondary angular space from a center point of the first adhesive layer.

2. The baseplate of claim 1, wherein the primary angular space spans a primary angle in the range from 45 ° to 315 °.

3. The baseplate of any one of claims 1 to 2, wherein the secondary angular space spans a secondary angle in the range from 45 ° to 315 °.

4. The base plate of any of claims 1 to 3, wherein the primary and secondary sensing areas are separate sensing areas.

5. The backplane of any of claims 1 to 4, wherein the first leakage electrode comprises one or more primary first sensing portions arranged in the primary sensing zone.

6. The backplane of any of claims 1 to 5, wherein the second leakage electrode comprises one or more primary second sensing portions arranged in the primary sensing zone.

7. The backplane of any of claims 1 to 6, wherein the second leakage electrode comprises one or more secondary second sensing portions arranged in the secondary sensing zone.

8. The backplane of any of claims 1 to 7, wherein the third leakage electrode comprises one or more secondary third sensing portions arranged in the secondary sensing zone.

9. The backplane of any of claims 1 to 8, wherein the plurality of electrodes are configured to detect the presence of fluid on the proximal side in a tertiary sensing zone arranged in a tertiary angular space from a center point of the first adhesive layer.

10. The baseplate of claim 9, wherein the tertiary angular spaces span tertiary angles in the range from 45 ° to 180 °.

11. The base plate of any of claims 9 to 10, wherein the primary and tertiary sensing areas are separate sensing areas.

12. The backplane of any of claims 9 to 11, wherein the first leakage electrode comprises one or more tertiary first sensing portions arranged in the tertiary sensing zone.

13. The backplane of any of claims 9 to 12, wherein the third leakage electrode comprises one or more tertiary third sensing portions arranged in the tertiary sensing zone.

14. A method for monitoring a base plate of an ostomy appliance, the base plate comprising a first adhesive layer having a proximal side configured for attaching the base plate to a skin surface of a user and a stoma opening with a center point, and a plurality of electrodes comprising a first leakage electrode, a second leakage electrode, and a third leakage electrode, the method comprising:

obtaining a primary sensor signal from the first leakage electrode and the second leakage electrode;

detecting a presence of fluid in a primary sensing zone on the proximal side based on the primary sensor signal;

obtaining a secondary sensor signal from the second leakage electrode and the third leakage electrode;

detecting a presence of fluid in a secondary sensing zone on the proximal side based on the secondary sensor signal; and

in response to detecting the presence of fluid in the primary and/or secondary sensing zones, providing a leak indicator to indicate that the sensing zone has been detected to be in the presence of liquid.

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